Zimmer Biomet recalls hip replacement cups due to unconfirmed safety of residual sterilant. Affected units may cause tissue reactions. 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 have untested residual sterilant. This could potentially cause tissue reactions in some users. The recall affects all units of this specific cup model.
The hip cup was sterilized using hydrogen peroxide, but the safety of any remaining sterilant wasn't confirmed. This could potentially cause tissue reactions in some users.
People who have received this specific hip cup model from Zimmer Biomet are affected. Those with hip replacements using this cup are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm' and item number 00-8065-546-32. All lots of this product are affected.
Identify if your hip cup matches the model name and item number described in the recall.
The recall states there is a potential for tissue reactions, but it cannot rule out this risk. The hazard level is low risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32mm, Neutral, O.D. Cup with Spacers, 49 mm' and item number 00-8065-546-32. All lots are affected.
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-0332-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0332-2021 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.
