Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific model numbers sold globally.
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, though the risk is not yet confirmed to be serious.
The hip cup component was sterilized using hydrogen peroxide, but the residual sterilant was not tested for biocompatibility. This could lead to adverse tissue reactions, though the risk is not yet confirmed to be serious.
Patients who received the specific hip cup model (ID 28 mm, 10 degree inclined face) from Zimmer Biomet are affected. Those with the recalled model are at risk of potential tissue reactions.
Check if your hip cup has the model ID 28 mm, 10 degree inclined face, and the specific number 00-8065-650-28. All lots of this model are affected.
Reach out to Zimmer Biomet directly to confirm if your hip cup is affected and get guidance on next steps.
The recall states there is a potential for adverse tissue reactions, but the risk is not confirmed to be serious. Zimmer Biomet cannot rule out the possibility.
Check if your hip cup has the model ID 28 mm, 10 degree inclined face, and the specific number 00-8065-650-28. All lots of this model are affected.
Contact Zimmer Biomet directly to confirm if your hip cup is affected and get guidance on 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-0373-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0373-2021 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.
