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

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

Recall # Z-2942-2020

  • Microport Orthopedics- PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. 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.

2021 Class II Recalls

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