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 could lead to health issues if the cups are used.
The sterilant (hydrogen peroxide) used in the cup was not tested for biocompatibility. This could cause tissue reactions, though the risk is not confirmed.
People who received the specific hip cup model (ID 22 mm, 10 degree inclined face) from Zimmer Biomet. Those with hip replacements using this cup are most at risk.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, ID 22 mm, 10 degree inclined face. All lots of this specific cup are affected.
Look for the model number 00-8065-654-22 on the cup packaging or label.
The recall states there is a potential for adverse tissue reactions, but the risk is not confirmed. Zimmer Biomet cannot rule out the possibility.
Check for the model number 00-8065-654-22 on the cup. All lots of this specific cup are affected.
The recall does not specify a remedy. Check with Zimmer Biomet 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-0379-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0379-2021 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.
