Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific model and all lots.
Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.
Zimmer Biomet is recalling hip replacement cups made with a specific polyethylene material because the sterilant used may cause tissue reactions. This could lead to health issues for people who have had the implant.
The sterilant (hydrogen peroxide) used in the hip cup may not have been fully tested for biocompatibility. This could lead to adverse tissue reactions, though the risk is not confirmed.
People who have received this specific hip cup implant are affected. Those with the implant are at risk of potential tissue reactions.
Check if your hip cup has the model number 00-8065-650-26. All lots of this specific cup are affected.
Look for the model number 00-8065-650-26 on your hip cup.
The recall states there is a potential for adverse tissue reactions, but the risk is not confirmed. Zimmer Biomet cannot rule out the possibility.
Check for the model number 00-8065-650-26 on your hip cup. All lots of this specific cup are affected.
The recall does not specify a remedy, so contact Zimmer Biomet for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0372-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0372-2021 from Zimmer 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.
