Biomet recalls specific knee implants due to potential elevated endotoxin levels exceeding safety limits. Affected products include Vanguard Knee System PS and AS Tibial Bearings with certain sizes and lot numbers. Contact Biomet for details.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling specific knee implants that may contain elevated endotoxin levels beyond safe limits. This could pose a risk to patients using these implants, though the exact health impact is not specified in the recall notice.
The recall is due to potential elevated endotoxin levels in the implants that exceed specified safety limits. Endotoxins are substances that can cause inflammation or infection in the body, but the recall does not specify the severity of health risks.
Patients who have received the recalled knee implants are most at risk. The recall applies to specific models and sizes of Biomet Vanguard Knee System components.
Check the product label for the model number and size: Vanguard Knee System PS Tibial Bearing (12 MM X 63/67 MM) or AS Tibial Bearing (18 MM X 67 MM). Also look for the UDI number starting with 443160 or 458440.
Look for the model number and size on the implant label to determine if it matches the recalled items.
The recall states potential elevated endotoxin levels that exceed the specified safety limits.
Check the product label for the model number and size: Vanguard Knee System PS Tibial Bearing (12 MM X 63/67 MM) or AS Tibial Bearing (18 MM X 67 MM). Also look for the UDI number starting with 443160 or 458440.
The recall does not specify a remedy, so users should check if their implant is affected and contact Biomet for further instructions.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2150-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2150-2020 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.
