Zimmer Biomet recalls hip replacement cups due to potential adverse tissue reactions from untested sterilant. Affected units include specific model 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 cause tissue reactions due to untested sterilant. This affects patients who received the specific cup model.
The hip cup was sterilized with hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could cause tissue reactions in some patients.
Patients who received the recalled hip cup model are affected. Those with the specific cup size and model are most at risk.
Check for the cup model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm size, 10 degree inclined face. All lots are affected.
Identify the cup model and size to confirm if it's affected.
The recall states there's a potential for adverse tissue reactions, so it's not safe to use without checking the recall.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm size, 10 degree inclined face. All lots are affected.
The recall does not specify a remedy, so contact Zimmer Biomet 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-0378-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0378-2021 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.
