Biomet recalls specific knee implants due to potential elevated endotoxin levels exceeding safety limits. Affected products include Vanguard Knee Systems with certain model numbers and lot codes. Consumers should contact Biomet for details.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling specific knee replacement implants because they may contain endotoxin levels higher than safe limits. This could pose a risk to patients using these implants, though the exact health impact isn't specified in the recall notice.
The recall is due to potential elevated endotoxin levels in the implants that exceed the manufacturer's safety specifications. Endotoxins are natural components of bacterial cell walls that can cause inflammation or infection if present in high concentrations.
Patients who have received the recalled knee implants from Biomet are most at risk. The recall affects specific model numbers and lot codes used in knee replacements.
Check the product label for model numbers like 'Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM' or 'Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM'. Look for lot numbers starting with UDI numbers such as 294130 or 509970.
Look for model numbers and lot codes on the implant packaging or label to determine if it is affected.
The implants may contain elevated endotoxin levels that exceed the manufacturer's safety specifications.
Check the product label for model numbers like 'Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM' or 'Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM' and lot numbers starting with UDI numbers such as 294130 or 509970.
The recall does not require immediate discontinuation of use; affected patients should 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-2153-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2153-2020 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.
