Biomet recalls specific knee prostheses due to potential elevated endotoxin levels exceeding specifications. Affected models include Vanguard Knee System Series-A Standard Patella, 28mm and 31mm. Consumers should contact Biomet for details.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling two specific knee prosthetic models because they may contain endotoxin levels higher than allowed. This could pose a risk to patients using these implants, though the exact health impact isn't specified in the recall.
The recall states that endotoxin levels in these knee prostheses may exceed the specified limits. Endotoxins are natural components of bacterial cell walls that can cause inflammation or infection if present in high amounts.
Patients who have received the recalled Vanguard Knee System Series-A Standard Patella models (28mm or 31mm) are affected. Those with these specific implants are most at risk.
Check for the model name 'Vanguard Knee System, Series-A Standard Patella' with either 28mm or 31mm size. The UDI number starts with 508390 for 28mm or 309810 for 31mm.
Reach out to Biomet directly for specific guidance on the recalled products and next steps.
The recalled models are Vanguard Knee System, Series-A Standard Patella, 28mm and 31mm.
Check for the model name 'Vanguard Knee System, Series-A Standard Patella' with either 28mm or 31mm size, and look for the UDI number starting with 508390 (28mm) or 309810 (31mm).
The recall mentions potential elevated endotoxin levels exceeding specifications, but does not specify a risk of serious injury or death.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2154-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2154-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
