Biomet recalls specific knee replacement systems due to potential elevated endotoxin levels exceeding specifications. Affected products include Vanguard Knee Systems with certain model numbers and lot numbers. Consumers should contact Biomet for details.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling specific knee replacement systems that may contain elevated endotoxin levels beyond safety limits. This could pose a risk to patients using these implants, though the exact health impact is not specified in the recall.
The recalled knee products may contain endotoxin levels that exceed the manufacturer's specifications. Endotoxins are natural components of bacterial cell walls that can cause inflammation or infection if present in high concentrations in medical implants.
Patients who have received the recalled knee replacement systems from Biomet are most at risk. The recall affects specific model numbers and lot numbers of the Vanguard Knee System.
Check for the model numbers listed in the recall: 189260, 189720, 189320, 189700, 189704. Also look for the lot numbers associated with the UDI numbers provided in the description.
Review the model numbers and lot numbers listed in the recall to determine if your knee replacement system is affected.
The recalled products may contain elevated endotoxin levels that exceed the manufacturer's specifications.
Check for the model numbers 189260, 189720, 189320, 189700, or 189704 and the associated lot numbers provided in the recall.
Contact Biomet directly to confirm if your product is affected and to receive 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-2151-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2151-2020 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.
