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 made with a specific type of polyethylene. The sterilant used in the cups wasn't tested for biocompatibility, which could cause tissue reactions.
The sterilant (hydrogen peroxide) used in the hip cup wasn't tested to ensure it's safe for body tissue. This could lead to adverse reactions like inflammation or tissue damage.
Patients who received this specific hip cup model during surgery are affected. Those with the described model and all lots are at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 22 mm, 10 degree inclined face, and lot number 00-8065-658-22. All lots of this model are affected.
Your surgeon can confirm if you have the affected hip cup model and provide next steps.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. This is a low-risk hazard.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 22 mm, 10 degree inclined face, and lot number 00-8065-658-22. All lots of this model are affected.
Contact your surgeon to confirm if you have the affected model and get guidance on 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-0387-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0387-2021 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.
