Zimmer Biomet recalls hip replacement cups made with untested sterilant that could cause tissue reactions. Affected units include specific model numbers and all lots. Contact for return instructions.
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 untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the implants.
The hip cup was sterilized using hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could cause tissue reactions in the body.
Patients who received this specific hip cup implant are affected. Those with the model number 00-8065-652-26 are most at risk.
Check if your hip cup has the model number 00-8065-652-26. All lots of this specific model are affected.
Look for the model number 00-8065-652-26 on your hip cup.
The recall states there is a potential for adverse tissue reactions, but it cannot rule out the possibility. The exact risk level is not specified.
Check for the model number 00-8065-652-26 on your hip cup. All lots of this specific model are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly for further instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0376-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0376-2021 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.
