Biomet recalls specific knee implant models due to potential elevated endotoxin levels that may exceed safety specifications. Affected products include Vanguard M Partial Knee System MonoBlock Tibial Trays with certain model numbers and lot codes.
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 recall does not indicate immediate harm to users.
The recalled implants may contain endotoxin levels 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 are most at risk. The recall applies to specific model numbers and lot codes used in the Vanguard M Partial Knee System.
Check the product label for model numbers like B8, D5, D6, B6, B7, C5, C8, D4, etc. Also look for lot codes such as 570440, 548700, 560400, and others listed in the recall notice.
Look for model numbers and lot codes on the implant packaging or label to determine if it is affected.
The recall does not require immediate discontinuation; affected users should check the product label for model numbers and lot codes.
The recall states potential elevated endotoxin levels, but does not specify the likelihood or severity of infection.
Check the product label for model numbers and lot codes listed in the recall notice, such as B8, D5, D6, B6, B7, C5, C8, D4, etc.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2155-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2155-2020 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.
