Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific model with ID 32 mm, 10 degree face.
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 that may have unconfirmed risks from residual sterilant. This could potentially cause adverse tissue reactions, so affected users should contact the company for guidance.
The hip cup component was sterilized with hydrogen peroxide, but the company did not confirm if the remaining sterilant is safe for body tissue. This could lead to adverse reactions like inflammation or tissue damage.
People who received the specific hip cup model with ID 32 mm, 10 degree inclined face, and O.D. Cup with Spacers. Those with hip replacements using this component are most at risk.
Check if your hip cup has the ID 32 mm, 10 degree inclined face, O.D. Cup with Spacers, and the model number 00-8065-646-32. All production lots are affected.
Reach out to Zimmer Biomet directly for specific guidance on your hip cup model.
The recall states there is a potential for adverse tissue reactions, but the company cannot confirm if the residual sterilant causes harm. This is not confirmed as dangerous.
Check for the model ID 32 mm, 10 degree inclined face, O.D. Cup with Spacers, and the specific model number 00-8065-646-32. All production lots are affected.
Contact Zimmer Biomet directly for specific guidance on your hip cup model. The company does not provide a direct remedy in this recall notice.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0366-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0366-2021 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.
