Zimmer Biomet recalls hip replacement cups due to potential adverse tissue reactions from untested sterilant residue. Affected units include specific model and all lots. Consumers should contact for details.
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 residue, which could cause tissue reactions. This affects patients who received the specific cup model and all lots of the product.
The hip cup component was sterilized using hydrogen peroxide, but the residual sterilant was not tested for biocompatibility. This could lead to adverse tissue reactions, though the exact risk is not confirmed.
Patients who received the ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene hip prosthesis component are affected. Those with the specific model and all lots are at risk.
Check for the model number 00-8065-948-32 on the hip cup. All lots of this specific product are affected.
Reach out to Zimmer Biomet for specific instructions on how to handle the recalled hip cup.
The recall states there is a potential for adverse tissue reactions, but the exact risk is not confirmed.
Contact Zimmer Biomet for specific instructions on handling the recalled hip cup.
Check for the model number 00-8065-948-32 on the hip cup; all lots are affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0392-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0392-2021 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.
