Zimmer Biomet recalls hip replacement cups due to potential tissue reactions from untested sterilant. Affected units include specific model and all lots. Contact for return instructions.
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 with a 26mm internal diameter.
The sterilant (hydrogen peroxide) used in the hip cup was not tested for biocompatibility. This could lead to adverse tissue reactions, though serious injury is not confirmed.
Patients who received the ZCA All Poly Acetabular Cup with specific model details (26mm internal diameter, 10-degree inclined face) are affected. Those with hip replacements using this cup model are most at risk.
Check if your hip cup has a 26mm internal diameter, 10-degree inclined face, and includes spacers. All lots of this specific model are affected.
Reach out to Zimmer Biomet for instructions on returning the affected hip cup.
The recall states there is a potential for adverse tissue reactions but does not confirm serious injury risk.
Check for a 26mm internal diameter, 10-degree inclined face, and spacers. All lots of this specific model are affected.
Contact Zimmer Biomet for return instructions as the recall does not specify a remedy.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0368-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0368-2021 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.
