Device Recall Information

Medical Device Recalls

MARCQI posts Class I and Class II recalls that involve implantable devices because of the risk to patients. For reference, the definitions of these classes, according to the Food and Drug Administration (FDA), are:

  • Class 1 recall: a situation in which there is a reasonable probability that the use of or exposure to a volatile product will cause serious adverse health consequences or death.
  • Class 2 recall:  a situation in which use of or exposure to a volatile product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
  • Class 3 recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
  • Medical Device Safety Alert: issued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
  • Correction or Removal: manufacturers and importers are required to make a report to FDA of any correction or removal of a medical device(s) if the correction or removal was initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health.

Class I Recalls (as of 11/6/2025)

September 2020

Recall # Z-2941-2020

  • Microport Orthopedics- PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component; All lots/serial numbers
    • MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation

Class II Recalls (updated 11/6/2025)

NOVEMBER 2025

Recall # Z-0418-2026, Z-0419-2026

  • Zimmer – Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene
    • Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing; Model/Catalog Number: 110031012; Lot Number 67160447 – Labeling mix-ups: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.
    • Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 46 mm O.D., Size G, Bearing; Model/Catalog Number: 110031013; Lot Number 67160480 – Labeling mix-ups: Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package is a Size G 46 mm, and vice versa.

OCTOBER 2025

Recall # Z-1048-2026, Z-0149-2026, Z-0150-2026, Z-0151-2026, Z-0152-2026, Z-0153-2026

  • BioPro, Inc. – Femoral Head
    • BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads; Model/Catalog: 18593 HEAD FEMORAL 22MM -3, 18594 HEAD FEMORAL 22MM +0, 19003 HEAD FEMORAL 28MM -6, 19004 HEAD FEMORAL 28MM -3, 19005 HEAD FEMORAL 28MM +0, 19006 HEAD FEMORAL 28MM +3, 19007 HEAD FEMORAL 28MM +6, 19008 HEAD FEMORAL 28MM +9, 19053 HEAD FEMORAL 36MM -3 ,19054 HEAD FEMORAL 36MM +0, 19055 HEAD FEMORAL 36MM +3, 19056 HEAD FEMORAL 36MM +6, 19057 HEAD FEMORAL 36MM +9, 19130 HEAD FEMORAL 32MM -6, 19131 HEAD FEMORAL 32MM -3, 19132 HEAD FEMORAL 32MM +0, 19133 HEAD FEMORAL 32MM +3, 19134 HEAD FEMORAL 32MM +6, 19135 HEAD FEMORAL 32MM +9; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
    • BioPro Endo Head (Metal uni-polar, 38-55); Model/Catalog: 10179 ENDO MD 38, 10180 ENDO MD 41, 10181 ENDO MD 43, 10182 ENDO MD 45, 10183 ENDO MD 47, 10184 ENDO MD 49, 10185 ENDO MD 51, 10186 ENDO MD 53, 10187 ENDO MD 55, 10188 ENDO SH 38, 10189 ENDO SH 41, 10190 ENDO SH 43, 10191 ENDO SH 45, 10192 ENDO SH 47, 10193 ENDO SH 49, 10194 ENDO SH 51, 10195 ENDO SH 53, 10196 ENDO SH 55; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
    • BioPro Bipolar Head; Model/Catalog: 18130 BIPOLAR HEAD 38MM, 18131 BIPOLAR HEAD 39MM, 18132 BIPOLAR HEAD 40MM, 18133 BIPOLAR HEAD 41MM, 18134 BIPOLAR HEAD 42MM, 18135 BIPOLAR HEAD 43MM, 18136 BIPOLAR HEAD 44MM, 18137 BIPOLAR HEAD 45MM, 18138 BIPOLAR HEAD 46MM, 18139 BIPOLAR HEAD 47MM, 18140 BIPOLAR HEAD 48MM, 18141 BIPOLAR HEAD 49MM, 18142 BIPOLAR HEAD 50MM, 18143 BIPOLAR HEAD 51MM, 18144 BIPOLAR HEAD 52MM, 18145 BIPOLAR HEAD 53MM, 18146 BIPOLAR HEAD 54MM, 18147 BIPOLAR HEAD 55MM, 18148 BIPOLAR HEAD 56MM, 18149 BIPOLAR HEAD 57MM, 18150 BIPOLAR HEAD 58MM, 18151 BIPOLAR HEAD 59MM, 18152 BIPOLAR HEAD 60MM; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
    • BioPro Femoral Head (Ceramic heads 28-30); Model/Catalog: 19023 HEAD FEMORAL CERAMIC 28MM -3, 19024 HEAD FEMORAL CERAMIC 28MM +0, 19025 HEAD FEMORAL CERAMIC 32MM -3, 19026 HEAD FEMORAL CERAMIC 32MM +0, 19027 HEAD FEMORAL CERAMIC 32MM +3; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
    • BioPro Endo Head (Ceramic); Model/Catalog: 13006 ENDO MODULAR CERAMIC SH 38, 13012 ENDO MODULAR CERAMIC SH 51, 13013 ENDO MODULAR CERAMIC MD 38, 13019 ENDO MODULAR CERAMIC MD 51, 13007 ENDO MODULAR CERAMIC SH 41, 13008 ENDO MODULAR CERAMIC SH 43, 13009 ENDO MODULAR CERAMIC SH 45, 13010 ENDO MODULAR CERAMIC SH 47, 13011 ENDO MODULAR CERAMIC SH 49, 13014 ENDO MODULAR CERAMIC MD 41, 13015 ENDO MODULAR CERAMIC MD 43, 13016 ENDO MODULAR CERAMIC MD 45, 13017 ENDO MODULAR CERAMIC MD 47, 13018 ENDO MODULAR CERAMIC MD 49, 14823 ENDO MODULAR CERAMIC SH 53, 14824 ENDO MODULAR CERAMIC MD 53, 14825 ENDO MODULAR CERAMIC SH 55, 14826 ENDO MODULAR CERAMIC MD 55, 17295 ENDO MODULAR CERAMIC SH 36, 17296 ENDO MODULAR CERAMIC MD 36; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
    • BioPro Femoral Head; Model/Catalog: 14089 HEAD FEMORAL 28 SH LT, 14090 HEAD FEMORAL 28 MD LT, 14091 HEAD FEMORAL 28 LG LT, 14094 HEAD FEMORAL 32 SH LT, 14095 HEAD FEMORAL 32 MD LT, 14096 HEAD FEMORAL 32 LG LT; All lots, all serial numbers – Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.

SEPTEMBER 2025

Recall # Z-2423-2025, Z-2424-2025, Z-2425-2025

  • Onkos Surgical – ELEOS Segmental Limb Salvage System Canal Filling Stems
    • ELEOS Bowed Canal Filling Stems; Model/Catalog Number: 2500BP20E, 2500BP22E; UDI: B2782500BP20E0, B2782500BP22E0; Lot: All lots released prior to 2025-07-11 – Due to unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
    • ELEOS Segmental Steam Canal Filling Straight Slotted Splined ⅔ Plasma; Model/Catalog Number: 2500CP16E; UDI: B2782500CP16E0; Lot: All lots released prior to 2025-07-11 – Due to unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
    • ELEOS Stem Extension, Straight, Splined, Slotted; Model/Catalog Number: KSP17100E, KSP17140E, KSP18100E, KSP18140E, KSP20100E, KSP20140E, KSP22100E; UDI: B278KSP17100E0, B278KSP17140E0, B278KSP18100E0, B278KSP18140E0, B278KSP20100E0, B278KSP20140E0, B278KSP22100E0; Lot: All lots released prior to 2025-07-11 – Due to unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

JULY 2025

Recall # Z-2147-2025, Z-2148-2025

  • Encore Medical (DJO Surgical) – EMPOWR Dual Mobility
    • EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40; Model/Catalog Number: 952-28-40E, GTIN: 00190446673194, Lot: 2224A1124A – Due to packaging discrepancy with the incorrect inserts/implants being packaged. Issued discovered via a customer complaint.
    • EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42; Model/Catalog Number: 952-28-42F, GTIN: 00190446673200, Lot: 2225A1124 – Due to packaging discrepancy with the incorrect inserts/implants being packaged. Issued discovered via a customer complaint.

Recall # Z-2125-2025, Z-2126-2025

  • Encore Medical (DJO Surgical) – EMPOWR 3D KNEE TIBIAL INSERT – E-PLUS
    • EMPOWR 3D KNEETM INS, 11L 10MM, VE; Model/Catalog Number: 341-10-711, GTIN: 00888912166881, Lot: 071T1084 – Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
    • EMPOWR 3D KNEETM INS, 11L 12MM, VE; Model/Catalog Number: 341-12-711, GTIN: 00888912166980, Lot: 115T1077 – Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

APRIL 2025

Recall # Z-1645-2025, Z-1646-2025, Z-1647-2025, Z-1648-2025, Z-1649-2025

  • Zimmer – Zimmer Biomet Ceramic Head
    • Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented – The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
    • Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented – The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
    • Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented – The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
    • Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented – The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
    • Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-Porous, Uncemented – The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

March 2025

Recall # Z-1329-2025

  • Zimmer – Zimmer Z1 Femoral Hip System Offset Stem Inserter
    • Zimmer Z1 Femoral Hip System, Product Number 611777612, Lot Numbers: 102646, 102777, 102778, 104095, 104324, 105277 – There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.

Recall # Z-1328-2025

  • Stryker – CinchLock Flex Knotless Anchor with Inserter and Suture
    • Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Lot # 23342AE2 & 24190AE2 – Increase in complaints concerning “pullwire” breakage that may result in the broken pullwire remaining in the anchor implant body after deployment.

Recall # Z-2219-2024

  • Stryker – Hoffman LRF Wire Tensioner
    • Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, Lot # J43995 – The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

Recall # Z-2155-2024, Z-2156-2024, Z-2157-2024, Z-2158-2024

  • Exactech – OPTETRAK Patella
    • OPTETRAK Three Peg Patella, Item Numbers: 200-02-26, 26MM; 200-02-29, 29MM; 200-02-32, 32MM; 200-02-35, 35MM; 200-02-38, 38MM; 200-02-41, 41MM – Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
    • OPTETRAK One Peg Patella, Item Numbers: 200-03-26, 26MM; 200-03-29, 29MM; 200-03-32, 32MM; 200-03-35, 35MM; 200-03-38, 38MM; 200-03-41, 41MM – Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
    • OPTETRAK Inset Patella, Item Numbers: 200-05-23, 23MM; 200-05-26, 26MM; 200-05-29, 29MM – Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
    • OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers: 200-07-26, 26MM; 200-07-29, 29MM; 200-07-32, 32MM; 200-07-35, 35MM; 200-07-38, 38MM – Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

Recall # Z-1621-2024, Z-1623-2024, Z-1627-2024, Z-1626-2024; Z-1632-2024, Z-1628-2024, Z-1629-2024, Z-1630-2024, Z-1631-2024; Z-1263-2024, Z-1264-2024, Z-1266-2024

  • Howmedica (Stryker) – TRIDENT II HEMI CLUSTER
    • TRIDENT II HEMI CLUSTER 44B, Catalog Number: 702-11-44B – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II HEMI CLUSTER 50D, Catalog Number: 702-11-50D – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II HEMI CLUSTER 66H, Catalog Number: 702-11-66H – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II HEMI CLUSTER 58F, Catalog Number: 702-11-58F – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
  • Howmedica (Stryker) – TRIDENT II PSL CLUSTER
    • TRIDENT II PSL CLUSTER 64H, Catalog Number: 742-11-64H – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II PSL CLUSTER 48D, Catalog Number: 742-11-48D – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II PSL CLUSTER 50D, Catalog Number: 742-11-50D – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell. 
    • TRIDENT II PSL CLUSTER 52E, Catalog Number: 742-11-52E – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
    • TRIDENT II PSL CLUSTER 58F, Catalog Number: 742-11-58F – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.
  • Howmedica (Stryker) – TRIATHLON TS TOTAL KNEE SYSTEM
    • NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM, Part No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028 – Potential packaging breaches of inner blister and outer sterile blister.
    • NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM, Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028 – Potential packaging breaches of inner blister and outer sterile blister.
    • NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM, Part No. 5537-G-513-E; GTIN: 07613327287813; Lot No. 9M3A91, EV0DV0; Expiration Date: 10/07/2028 – Potential packaging breaches of inner blister and outer sterile blister.

Recall # Z-1608-2024

  • Zimmer – NexGen CR-Flex Femoral Component
    • NexGen CR-Flex Femoral Component, Size E and Size E Minus (E-), Item No. 00595201501, 00595201502, 00595201505, 0059520150 – Out of specification violation of devices that results in a gap existing within the fixture that presses the fiber metal pad to the substrate, causing the pad to not fully bond to the substrate.

Recall # Z-1299-2024

  • Waldemar Link GmbH & Co. KG (Mfg Site) – SPII Model Lubinus, Long Stem Prosthesis
    • SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

October 2024

Recall # Z-3171-2024

  • Smith & Nephew – DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042
    • DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener, Batch 23GNX0077 – Packaging error: a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.

Recall # Z-3172-2024

  • Smith & Nephew – DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062
    • DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener, Batch 21KNX0074 – Packaging error: a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label.

September 2024

Recall # Z-3132-2024

  • Zimmer GmbH – Biolox Option Taper Sleeve, Type 1 Taper
    • Biolox Option Taper Sleeve, Type 1 Taper, Standard Neck, Item Number: 650-1066, Lot Number: 3185263 – Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6.

Recall # Z-3133-2024

  • Zimmer GmbH – Biolox Option Taper Sleeve, Type 1 Taper, 6mm Neck
    • Biolox Option Taper Sleeve, Type 1 Taper, -6mm Neck, Item Number: 650-1064, Lot Number: 3185266 – Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etching as either STD or -6.

Recall # Z-2410-2024

  • Waldemar Link GmbH & Co. KG (Mfg Site) – LINK Endo Model M Tibial Components
    • Endo Model M Tibial Components Modular Knee Prosthesis System, Model/Catalog Number: Various sizes, all product lots manufactured since 01-Jun-2022 – Process design, blind screws of the modular tibial component cannot be loosened intraoperatively, prolongation surgery due to intraoperatively change in procedure, probably to cementing technique.

Recall # Z-2411-2024

  • Waldemar Link GmbH & Co. KG (Mfg Site) – LINK Endo Model SL Tibial Components
    • Endo Model SL Tibial Components, Model/Catalog Number: Various sizes, all product lots manufactured since 01-Jun-2022 – Process design, blind screws of the modular tibial component cannot be loosened intraoperatively, prolongation surgery due to intraoperatively change in procedure, probably to cementing technique.

August 2024

Recall# Z-2450-2024 

  • CPT Hip Joint Metal
    • CPT HIP Joint Metal – Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty – Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.

Recall # Z-1934-2024  

  • Corentec – LOSPA Tibial Insert 
    • LOSPA Tibial Insert – Model/Catalog Number: Various sizes – Due to unsupported 10 year expiration date.

Recall # Z-1935-2024 

  • Corentec – LOSPA Patella Component
    • LOSPA Patella Componenet – Model/Catalog Number: 01.10.9XX – Due to unsupported 10 year expiration date

June 2024

Recall # Z-1265-2024 

  • Stryker – Triathlon Total Knee System
    • NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM, Catalog number 5537-G-416-E, Potential packaging breaches of inner blister and outer sterile blister.

Recall # Z-1625-2024

  • Stryker – TRIDENTII HEMI CLUSTER
    • TRIDENTII HEMI CLUSTER54E, Catalog number 702-11-54E – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell

Recall # Z-1624-2024

  •  Stryker – TRIDENTII HEMI CLUSTER
    • TRIDENTII HEMI CLUSTER52E, Catalog number 702-11-52E – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.

Recall # Z-1622-2024 

  • Stryker – TRIDENTII HEMI CLUSTER
    • TRIDENTII HEMI CLUSTER48D, Catalog number 702-11-48D – The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell.

May 2024

Recall #  Z-1260-2024  

  • Stryker – Triathlon Total Knee System
    • Triathlon Total Knee System, X3 TRIATHLON CS INSERT NO 6 10 MM – The reason for the recall is potential packaging breaches of the inner blister and outer sterile blister

April 2024

Recall # Z-1298-2024 

  • Waldemar Link GmbH & Co. KG (Mfg Site) – SPII Model Lubinus, Hip Prosthesis Stem 
    • SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Recall # Z-1297-2024  

  • Waldemar Link GmbH & Co. KG (Mfg Site) – SPII Model Lubinus, Hip Prosthesis Stem 
    • SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Recall # Z-1296-2024 

  • Waldemar Link GmbH & Co. KG (Mfg Site) – SPII Model Lubinus, Hip Prosthesis Stem 
    • SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented – Due to two complaints, additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

2023 Class II Recalls (updated 11/28/2023)

November 2023

Recall # Z-0214-2024  

  • Corin – Unity Total Knee System
    • Unity Total Knee System, Model Number 112.001.34.- Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labeled as Unity CR Inserts Right size 7 from batch 532405 and visa versa.

Recall # Z-0213-2024  

  • Corin – Unity CR Femur Right, Size 6,
    • Unity CR Femur Right, Size 6, Model Number 112.001.32 – Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly labeled as Unity CR Inserts Right size 7 from batch 532405 and visa versa

Recall #  Z-0158-2024 

  • Smith & Nephew – JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left
    • JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis – The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Recall # Z-0157-2024  

  • Smith & Nephew – JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6,
    • JOURNEY  II BCS Articular Insert REF 74027262; knee prosthesis- The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. Also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled, and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM

 

October 2023

Recall # Z-2519-2023 

  • Zimmer – M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 and Size 6 – Reason for recall is mixed-up of materials/components. The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

June 2023

Recall # Z-1673-2023 

  • Smith & Nephew –  ENGAGE Cementless Partial Knee System, Coated Tibial Insert,
    • ENGAGE Cementless Partial Knee System, Coated Tibial Insert- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall # Z-1672-2023  

  • Smith & Nephew – ENGAGE Cementless Partial Knee System, Coated Tibial Tray, SZ 1 Left Medial
    • ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall #  Z-1671-2023 

  • Smith & Nephew –  ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, SZ 1-2; Unicondylar knee prosthesis
    • Smith & Nephew – ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6); Unicondylar knee prosthesis- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Recall # Z-1670-2023  

  • Smith & Nephew –  ENGAGE Cementless Partial Knee System, Porous Femoral components, various sizes
    • Smith & Nephew – ENGAGE Cementless Partial Knee System, Porous Femoral components, various sizes- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

April 2023

Recall # Z-1393-2023   

  • Smith & Nephew – JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
    • JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Recall # Z-1294-2023 

  • Zimmer-CoCr Femoral Head, XS, 38/-8, Taper 12/14  Item Number: 01.01012.384
    • CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384 received an Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard 

Recall # Z-1284-2023

  • Biomet – G7 Acetabular System, Dual Mobility Acetabular Liner, 40mm, Size D, Model # 110024462
    • G7 Acetabular System, Dual Mobility Acetabular Liner, 40mm, Size D, Model # 110024462 has an outer package where the labeling and product etch are a 40mm Site D liner, however, the implant is a 38mm Size C liner

Recall # Z-1263-2023, Z-1264-2023, Z-1265-2023, Z-1266-2023, Z-1267-2023

  • DePuy – Attune Revision Tibial Insert, various sizes
    • Attune Revision Tibial Insert (various sizes) received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties

March 2023

Recall # Z-1733-2022, Z-1732-2022, Z-1731-2022, Z-1730-2022, Z-1734-2022, Z-1728-2022, Z-1727-2022, Z-1726-2022, Z-1729-2022

  • Exactech – GXL acetabular liners, various sizes
    • Specific GLX acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear

Recall # Z-1850-2021, Z-1851-2021

  • Corin Ltd – Corin TriFit, various sizes, hip prosthesis component
    • Corin TriFit has units from one batch where TS size 2 stem were found to be labeled as a TriFit CF size 7 stem. And vice versa.

Recall # Z-1509-2022

  • Corin Ltd – Corin METAFIX Hip Stem, size 3, standard, 135 degrees, collard hip stem, cementless, part number: 579.0103
    • Corin METAFIX size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630

Recall # Z-1725-2022, Z-1726-2022, Z-1727-2022

  • Exactech – GXL acetabular liners
    • Specific GLX acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear

Recall # Z-0007-2023

  • Zimmer – G7 Acetabular System, Acetabular Shell
    • G7 Acetabular System, Acetabular Shell has outer sterile package cavity with a corner wall thickness that is below the specification. this corner wall could potentially crack during transit. potential risks include non-clinically or clinically significant extension of surgery or infection leading to surgical intervention

Recall # Z-0275-2023, Z-0276-2023

  • MicroPort Orthopedics – Evolution MP Tibial Bases, various sizes
    • Evolution MP Tibial Bases, various sizes has 1 confirmed incident where ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgers and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging

Recall # Z-0273-2023

  • Corin Ltd – Utility Total Knee System
    • The Utility Total Knee System’s internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging

Recall # Z-0466-2023, Z-0467-2023, Z-0468-2023, Z-0469-2023, Z-0470-2023, Z-0471-2023

  • Zimmer – NexGen option stemmed tibial component, various sizes
    • Nextgen option stemmed tibial component, various sizes, has clinically and statistically significant higher overall revision rates when these tibial components are used with either the legacy posterior stabilized flex or LPS flex gender solutions femoral components as compared to other total knee arthroplasties in the United Kingdom National joint registry

Recall # Z-0951-2023

  • Depuy – Biostop F Bioresorbable Cement Restrictor
    • Biostop F Bioresorbable Cement Restrictor is being removed as a precautionary measure because tested endotoxin levels were higher than recommended by the current FDA regulatory guidance…endotoxins have a potental to initiate inflammatory responses, ranging from a mild fever to potentially impact or damage to vital organs

Recall # Z-0726-2023, Z-0727-2023

  • Corin Ltd – Corin BIOLOX Delta Mod Head, various sizes
    • Corin BIOLOX Delta Mod Head size 36xl is labelled as the size 32xl and vice-versa

2022 Class II Recalls (updated 3/18/2022)

March 2022

Recall # Z-0670-2022

  • Biomet – Acros Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma, Size A, 60 MM; item number: 11-301301
    • Acos Modular Revision Hip System, Standard Cone Prox Body, Porous Plasma in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength

2021 Class II Recalls

November 2021

Recall # Z-0160-2022, Z-0159-2022

  • Limacorporate S.P.A. – Bone Screw/ Vite, various sizes (ref 8420.15.010 and 8420.15.020)
    • Limacorporate S.P.A. Bone Screw/ Vite, various sizes, has a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included

September 2021

Recall # Z-2515-2021, Z-2514-2021, Z-2509-2021, Z-2510-2021, Z-2511-2021, Z-2512-2021, Z-2513-2021

  • Aesculap – Univation X System Knee Implant Devices, various sizes
    • Univation X System knee implant devices could malfunction, loosening the implant resulting in a potential revision surgery

Recall # Z-2348-2021

  • Depuy – Attune Revision Cemented Stem 16×80 mm
    • Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement

August 2021

Recall #s Z-2264-2021, Z-2275-2021, Z-2265-2021, Z-2264-2021, Z-2263-2021, Z-2262-2021, Z-2266-2021, Z-2271-2021, Z-2272-2021, Z-2270-2021

  • Biomet- Arcos Modular Revision Hip System High Offset Cone Proximal Body- Various sizes
    • Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Recall #s Z-2273-2021, Z-2269-2021, Z-2268-2021, Z-2267-2021, Z-2261-2021, Z-2262-2021, Z-2260-2021, Z-2259-2021, Z-2274-2021

  • Arcos Modular Revision Hip System Standard Cone Proximal Body, various sizes
    • o Arcos Proximal Cone Bodies could potentially exhibit chatter in the inner taper fretting corrosion and device failure in vivo leading to surgical intervention

Recall #s Z-2250-2021, and Z-2251-2021

  • Exactech- BIOLOX delta Femoral Head, 36m O.D.
    • o Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 10-36-03 (36mm +3.5)

Recall #s Z-2242-2021

  • Smith & Nephew- BHR Square Headed Nail Ref Catalog # 999908
    • The nail head may become detached during surgery.

Recall #s Z-2133-2021, Z-2132-2021, Z-2115-2021, Z-2116-2021, Z-2117-2021, Z-2118-2021, Z-2119-2021, Z-2120-2021, Z-2121-2021, Z-2122-2021, Z-2123-2021, Z-2124-2021, Z-2126-2021, Z-2127-2021, Z-2128-2021, Z-2129-2021

  • Exactech Connexion GXL acetabular polyethylene liners used in various systems for hip arthroplasty procedures
    • Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning

Recall #Z-2107-2021

  • Arthrex- Anchor Suture
    • Not properly sterilized, because the outer pouch seal on the Tyvek header was sealed closely to the foil pouch

July 2021

Recall # Z-2774-2020

  • Smith & Nephew- Tibial Knee Prosthesis
    • Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

Recall # Z-0118-2021

  • Smith & Nephew- Genesis (GII)
    • The anterior locking detail does not meet its design specifications.

Recall #s Z-2331-2020, Z-2332-2020, Z-2333-2020, Z-2334-2020, Z-2335-2020, Z-2336-2020

  • Smith & Nephew- R3 Coated Shells (various models)
    • A manufacturing error resulted in out of specification R3 Acetabular Shells

February 2021

Recall # Z-0802-2021

  • Depuy Orthopaedics, Inc.- Pinnacle Cups, Various Catalog Numbers and Lot Numbers
    • Certain Pinnacle Cup devices may potentially exhibit an oversized “minor diameter”, which could lead the Apex HE to thread through the shell of the cup without stopping or to protrude internally as a result of “cross-threading”. If cross-threading occurs, physicians will not feel the positive stop of the Apex HE against the cup.

2020 Class II Recalls

November 2020

Recall # Z-0332-2021

  • Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm. Catalog Number: 8065-546-32 All Lot numbers.
    • Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions

Recall # Z-0344-2021

  • Zimmer Biomet- ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Neutral, O.D. Cup with Spacers, 55 mm. Catalog Number: 00-8065-552-32. All Lot numbers.
    • Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions

October 2020

Recall # Z-0057-2021

  • Zimmer Biomet- Dual Mobility Vivacit-E Bearing, Model Number 110031009; Lot Number 64755636
    • The outer package is labeled as a Size C 38 mm, however, the implant inside the package is a Size E 42 mm

Recall # Z-0081-2021

  • Zimmer Biomet- Regenerex Primary Taper Cap Item Number 141269; Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610
    • Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized

Recall # Z-0097-2021

  • Zimmer Biomet- Hip Products
    1. RingLoc Bi-Polar Hip System Acetabular Cup ArCom:
      Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM:
      Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930
    2. RingLoc Hip system Acetabular Bi-Polar Cup:
      Acetabular Cup, ArCom, 41 MM OD, 28 MM ID:
      Item No. 11-165206, Lot No. 649750; UDI No. (01) 00880304001923 (17) 230614 (10) 649750
    3. RingLoc Bi-Polar Hip System Acetabular Cup ArCom:
      Acetabular Cup, ArCom, 52 MM OD, 28 MM ID:
      Item No. 11-165228; Lot No. 433290; UDI No. (01) 00880304001930 (17) 230612 (10) 433290

      • The affected lots were gamma sterilized twice. Sufficient data does not exist to support the functionality, shelf life, or package integrity for more than one-time sterilization.

August 2020

Recall # Z-2948-2020

  • MicroPort Orthopedics- PROFEMUR Titanium and Cobalt Chrome modular necks
    • MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8)

Recall # Z-2849-2020

  • Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
    Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)

    • Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920

May 2020

Recall # Z-2145-2020

  • Zimmer Biomet- Hip Products
    Item Number:
    1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM
    2) 11-165218 RingLoc Bi-Polar Hip System, Acetabular Cup, 28 MM X 47 MM
    3) XL-105916 588500 RingLoc Hip System, Acetabular Liner, 36 MM, Size 26

    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2146-2020

  • Zimmer Biomet- Knee Products:
    1) 141356 Regenerex Series-A Patella 3 Peg, 31 MM
    2) 141358 Regenerex Series-A Patella 3 Peg, 37 MM

    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2147-2020

  • Zimmer Biomet- Knee Product: 150414 Orthopedic Salvage System (OSS) Tibial Bearing, 20 MM Standard; Lot Numbers: UDI Number 292720 (01)00880304006492(17)211222(10)292720
    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2149-2020

  • Zimmer Biomet- Knee Products: AGC Knee System PS Molded Tibial Component, various product and lot numbers
    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2150-2020

  • Zimmer Biomet- Knee Products:
    1. 183622 Vanguard Knee System PS Tibial Bearing, 12 MM X 63/67 MM
    2. 183620 Vanguard Knee System PS Tibial Bearing, 10 MM X 63/67 MM
    3. 189048 Vanguard Knee System, AS Tibial Bearing, 18 MM X 67 MM
    4. 189082 Vanguard Knee System, AS Tibial Bearing, 12 MM X 75 MM
      • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2151-2020

  • Zimmer Biomet- Knee Products:
    1. 189260 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 71 MM
    2. 189720 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 83 MM
    3. 189320 Vanguard Knee System, CR-L Mono Lock Tibial Bearing, 10 MM X 83 MM
    4. 189700 Vanguard Knee System, CR Mono Lock Tibial Bearing, 10 MM X 79 MM
    5. 189704 Vanguard Knee System, CR Mono Lock Tibial Bearing, 14 MM X 79 MM
      • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2152-2020

  • Zimmer Biomet- Knee Products: Vanguard Knee System, PS Mono Lock Tibial Bearing; various product and lot numbers
    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2153-2020

  • Zimmer Biomet- Knee Products: Vanguard Knee System, PS/PS+ Tibial Bearing; various product and lot numbers
    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2154-2020

  • Zimmer Biomet- Knee Products:

1) 184762 Knees Vanguard Knee System, Series-A Standard Patella, 28 MM;
2) 184764 Knees Vanguard Knee System, Series-A Standard Patella, 31 MM

  • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2155-2020

  • Zimmer Biomet- Knee Products: Vanguard M Partial Knee System MonoBlock Tibial Tray, various product and lot numbers
    • Potential presence of elevated endotoxin levels that exceed the specification limit

Recall # Z-2156-2020

  • Zimmer Biomet- Knee Product: TMJPM-1510 Microfixation Custom Made Device, Left PM-TMJ Model (01)00841036226534(17)220111(10)735550
    • Potential presence of elevated endotoxin levels that exceed the specification limit

March 2020

Recall # Z-1478-2020

  • Aesculap Implant Systems LLC- Columbus R/PS TIB.PLATEAU Cemented, various sizes, Knee implant components, model nos.
    • Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging

Recall # Z-1479-2020

  • Aesculap Implant Systems LLC- COLUMBUS CR/PS TIB.PLAT.PLASMAPORE, Knee implant components, various sizes, model nos.
    • Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging

Recall # Z-1480-2020

  • Aesculap Implant Systems LLC – COLUMBUS CRA/PSA TIB.PLAT.CEMENTED, Knee implant components, various sizes, model nos.
    • Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging

Recall #: Z-1481-2020

  • Aesculap Implant Systems LLC – AS COLUMBUS CR/PS TIB.PLAT.CEMENTED, Knee implant components, various sizes, model numbers
    • Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

Recall # Z-1482-2020

  • Aesculap Implant Systems LLC- COLUMBUS REV F TIBIA OFFSET CEMENTED, Knee implant components, various sizes, model nos.
    • Low Density Polyethylene (LDPE) particles may be present on the surface of the implant upon the opening of the inner packaging.

2019 Class II Recalls

April

2018 Correction or Removal

2018 Class 2 Recalls

May

April

March

February

January

2017 Class 2 Recalls

July

  • MAKO RIO Robotic-arm
    • An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection

April

March

Field Safety Notice

February

January

Instruments

Biomet:

 

2016 Class 1 Recalls

Instrument

DuPuy Synthes Power Tool System Battery Adaptor

Greatbatch Medical Standard Offset Cup Impactor – Inadequate Sterilization

 

2016 Class 2 Recalls

Posted April, 2016

The following Class II Recall Notifications from Zimmer Biomet include a variety of catalog and lot numbers. The reason, cause, and action for each recall can be found in each of the .pdf documents listed here for your reference.  A link to the FDA website for each recall is also included at the bottom of each .pdf file.  Please review the details to determine any impact to your cases.

The reason, cause, and action for the recalls listed below is as described by the FDA on its website:

Manufacturer Reason for Recall

As a result of the insufficient sealer calibration data for product packaged in firm’s Building II between August 2010 and April 2013. The affected products are sterile.

FDA Determined Cause 2

Packaging

Action

Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to:

  1. Review the notification and ensure that relevant personnel are aware of the contents.
  2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product.
  3. Your Zimmer Biomet sales representative will remove the recalled product from your facility.
  4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com.
  5. If after reviewing this notification you have further questions or concerns please call

Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative

Instruments

November, 2016

October, 2016

September, 2016

August, 2016

June, 2016

2015 Class 1 Recalls

Zimmer M/L Taper with Kinectiv Technology Prosthesis Femoral Stems and Necks Higher than Expected Levels of Manufacturing Residues

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree

2015 Class ll Recalls

LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prosthesis component for orthopedic surgery

LCS COMPLETE RPS inserts various sizes. Knee prosthesis component for orthopedic surgery

Stryker Trident 10 degrees x 3 Insert 36 MM

Stryker Triathlon x3 Tibial Bearing Insert

Stryker Triathlon PS x3 Tibial Insert, No 3 Triatholon TS Plus Tibial Insert x 3 Poly 19 mm

Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component

NexGen System, Complete Knee Solution; Reference Number 5980-37-01; Tibial Component, Precoat, Stemmed Size 3

Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile

Instruments 

Stryker MIS Modular Distal Capture Triathlon MIS Instruments

SSS Reprocessed Zimmer, Synthes, Stryker and Linvatec Drill Bits and Blades

Zimmer UNIVERSAL Power System Loaner and Modular Electric/Battery Double Trigger Handpiece. Rx only Made in Switzerland