Biomet recalls specific knee prostheses due to potential elevated endotoxin levels exceeding safety limits. Affected units may pose health risks during use.
Potential presence of elevated endotoxin levels that exceed the specification limit
Biomet is recalling certain knee prostheses that may contain elevated endotoxin levels beyond safe limits. This could pose health risks to users during normal use.
Elevated endotoxin levels in the device may exceed safety specifications. Endotoxins are bacterial components that can cause inflammation or infection if they enter the body during surgery or implantation.
People with the specific knee prosthesis model (Left PM-TMJ) and lot number 735550 are affected. Those using this device for knee replacement surgery are most at risk.
Check for the model name 'Left PM-TMJ' and lot number 735550 on the device. This product was sold as a knee prosthesis for surgical use.
Look for the model name 'Left PM-TMJ' and lot number 735550 on the device.
The recall states potential elevated endotoxin levels exceeding safety limits, which could pose health risks during use.
Check for the model name 'Left PM-TMJ' and lot number 735550 on the device.
The recall does not specify a remedy, so contact Biomet directly for guidance.
We’ve drafted a message you can send Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-2156-2020 — Biomet Biomet Hello, I own a Biomet that is covered by recall Z-2156-2020 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.
