Zimmer Biomet recalls hip replacement cups made with untested sterilant. Residual hydrogen peroxide may cause tissue reactions. Affected units: All lots of ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 28mm.
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 if the cups are implanted.
The hip cup was sterilized with hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could cause tissue reactions if the cup is implanted.
People who received this hip cup implant during surgery are affected. Those with the specific cup model and size are at risk.
Check if you have the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 28mm model with the lot number 00-8065-656-28. All lots are affected.
Identify if you have the specific hip cup model and lot number mentioned in the recall notice.
No, only the specific model with the lot number 00-8065-656-28 is affected.
The recall notice does not specify a remedy, so contact Zimmer Biomet directly for guidance.
The recall states there is a potential for adverse tissue reactions, but it does not specify the risk level.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0385-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0385-2021 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.
