Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. Affected units include specific model numbers 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 that may have untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the device.
The sterilant used in the hip cup was not tested for biocompatibility. This could lead to adverse tissue reactions, though the exact risk level is not specified.
Patients who received this specific hip cup model during manufacturing are affected. Those with the described model and lot numbers are most at risk.
Check for the model number 00-8065-652-22 on the cup. All lots of this specific hip cup are affected.
Look for the model number 00-8065-652-22 on the hip cup.
The recall states the sterilant was not evaluated for biocompatibility, so there is a potential risk of adverse tissue reactions. The exact safety is not confirmed.
Check for the model number 00-8065-652-22 on the hip cup. All lots of this specific model are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly 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-0375-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0375-2021 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.
