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 users, so affected individuals should contact the company for details.
The hip cup was sterilized using hydrogen peroxide, but the company did not confirm that the remaining sterilant is safe for body tissue. This could potentially cause tissue reactions, though the exact risk is not confirmed.
People who received the specific hip cup model (ID 22 mm, 10 degree inclined face) from Zimmer Biomet are affected. Those with hip replacements using this cup are most at risk.
Check if your hip cup has the model ID 22 mm, 10 degree inclined face, and the part number 00-8065-640-22. All lots of this specific model are affected.
Reach out to Zimmer Biomet directly for specific guidance on your hip cup model and next steps.
The recall states there is a potential for adverse tissue reactions, but the exact risk is not confirmed. Zimmer Biomet cannot rule out this possibility.
Check if your hip cup has the model ID 22 mm, 10 degree inclined face, and part number 00-8065-640-22. All lots of this specific model are affected.
Contact Zimmer Biomet directly for specific guidance on your hip cup model and next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0357-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0357-2021 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.
