Zimmer Biomet recalls specific hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include all lots of the ZCA All Poly Acetabular Cup model.
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 a specific hip replacement cup model due to potential adverse tissue reactions from residual sterilant not fully tested for biocompatibility. This could affect patients who have received this type of hip implant.
The hip cup was sterilized using hydrogen peroxide, but the residual sterilant was not tested to ensure it would not cause tissue reactions. This could potentially lead to adverse reactions in the body.
Patients with this specific hip replacement cup model are affected. Those who have received the recalled cup and are experiencing unusual symptoms should contact their surgeon.
Check if your hip replacement cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene' with the specific item number 00-8065-554-22. All lots of this model are affected.
Look for the model name and item number on your hip replacement cup.
The recall states that residual sterilant was not evaluated for biocompatibility, but it cannot rule out the potential for adverse tissue reactions. The risk is not confirmed to cause serious injury.
Check if your cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene' with item number 00-8065-554-22. All lots of this model are affected.
The recall does not specify a remedy, so contact your surgeon to discuss potential next steps.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0345-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0345-2021 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.
