Zimmer Biomet recalls hip prosthetic cups made with untested sterilant that may cause tissue reactions. Affected units include specific model and size. Contact for return or repair 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 prosthetic cups that may have untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the implant.
The hip cup was sterilized using hydrogen peroxide, but the residual sterilant wasn't tested for biocompatibility. This could cause adverse tissue reactions in the body.
Patients who have received this specific hip cup implant are affected. Those with the 28mm size and 10-degree inclined face model are most at risk.
Check for the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 28mm, and 10-degree inclined face. All lots of this specific product are affected.
Reach out to Zimmer Biomet directly for instructions on returning or repairing the affected hip cup.
No, only specific models with 28mm size and 10-degree inclined face are affected.
Look for the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 28mm, and 10-degree inclined face. All lots of this product are affected.
Contact Zimmer Biomet directly for instructions on returning or repairing the affected hip cup.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0389-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0389-2021 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.
