Zimmer Biomet recalls hip replacement cups made with untested sterilant. Potential for adverse tissue reactions. Affected units: All lots of specific cup model.
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. This could cause adverse tissue reactions, though serious injury risk isn't confirmed.
Sterilant (hydrogen peroxide) used in the cup wasn't tested for biocompatibility. This could lead to adverse tissue reactions, but serious injury risk isn't confirmed.
People with this specific hip cup model who had surgery using the recalled product. Those with the cup's model number 00-8065-546-28 are most at risk.
Check if your hip cup has model number 00-8065-546-28. The product was sold as a specific cup size (28mm internal diameter) with spacers.
Look for model number 00-8065-546-28 on your hip cup.
The recall states potential for adverse tissue reactions but does not confirm serious injury risk.
Check for model number 00-8065-546-28 on your hip cup.
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-0331-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0331-2021 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.
