Zimmer Biomet recalls hip replacement cups due to potential adverse 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 made with a specific type of polyethylene. The sterilant used in the cups wasn't fully tested for safety, which could cause tissue reactions in some patients.
The sterilant (hydrogen peroxide) used in the cups wasn't tested enough to ensure it won't cause tissue reactions. This could lead to complications like inflammation or infection in some patients.
Patients who received this hip cup implant during the specified production period. Those with the exact model and lot numbers are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm' and lot number 00-8065-952-32. All lots of this specific model are affected.
Identify if your hip cup matches the model and lot number described in the recall notice.
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, I.D. 32 mm, Snap-In O.D. Cup with Spacers, 55 mm' and lot number 00-8065-952-32.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0394-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0394-2021 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.
