Biomet recalls specific Vanguard Knee System implants due to potential elevated endotoxin levels exceeding specifications. Affected units include certain sizes and lot numbers. Consumers should check their product details and contact Biomet for guidance.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling specific Vanguard Knee System implants that may contain elevated endotoxin levels beyond safety limits. This could pose a risk of infection or other complications during medical procedures.
The implants may contain endotoxin levels that exceed the manufacturer's safety specifications. Endotoxins are bacterial components that can cause infections or adverse reactions if introduced into the body during surgery.
Patients who have received one of the recalled Vanguard Knee System implants with specific dimensions and lot numbers. Those most at risk are individuals undergoing surgery with these implants.
Check if your implant has a specific size (e.g., 10 MM X 63 MM) and a lot number starting with UDI numbers like 530900, 548950, or 602870. The product details are listed in the recall notice.
Review your implant's size and UDI number to confirm if it matches the recalled models listed in the notice.
The implants may contain elevated endotoxin levels that exceed the manufacturer's safety specifications, potentially increasing infection risk during surgery.
Compare your implant's size (e.g., 10 MM X 63 MM) and UDI number (e.g., 530900) with the list of recalled models provided in the recall notice.
No action is required if your implant does not match the specific sizes and lot numbers listed in the recall notice.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2152-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2152-2020 from Biomet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
