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.

2020 Class I Recalls (updated 3/17/2023)

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

2024 Class II Recalls (updated 10/7/2024)

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