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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

Biomet, Inc.: Vanguard Knee System AS Tibial Bearing Recalled for Manufacturing Damage

Agency Publication Date: April 22, 2024
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Summary

Biomet, Inc. is recalling 19 units of the Vanguard Knee System AS Tibial Bearing (Model 189082) due to possible damage that occurred during the manufacturing process. These orthopedic implants, which are part of a knee replacement system, may have physical defects that compromise their integrity. The affected units were distributed worldwide, including one unit in the United States (specifically Indiana) and 18 units in Canada, India, the Netherlands, and China. Because these are surgical implants, consumers should contact their orthopedic surgeon or healthcare provider to determine if their specific implant is affected and what follow-up care is necessary.

Risk

The damaged tibial bearing may fail prematurely or cause improper joint function, potentially leading to pain, limited mobility, or the need for revision surgery to replace the defective component.

What You Should Do

  1. Check your medical records or contact your orthopedic surgeon to see if your knee replacement used the Vanguard Knee System AS Tibial Bearing, Model 189082.
  2. Specifically, confirm if your implant is from Lot Number 65966530 with UDI-DI (01)00880304436954(17)280413(10)65966530.
  3. If you have recently undergone knee surgery and are experiencing unusual pain, swelling, or instability, schedule an appointment with your healthcare provider immediately.
  4. Contact your healthcare provider or Biomet, Inc. (Zimmer Biomet) for further instructions regarding the status of your implant and potential next steps.
  5. For additional questions or to report adverse events, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Vanguard Knee System AS Tibial Bearing / DCM ArCom (12 MM X 75 MM)
Model / REF:
189082
Lot Numbers:
65966530

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94310
Status: Active
Manufacturer: Biomet, Inc.
Sold By: Hospitals; Medical facilities; Specialty retailers
Manufactured In: United States
Units Affected: 19 units (1 US, 18 OUS)
Distributed To: Indiana

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.