Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units: All lots of ZCA All Poly Acetab: 32mm, 53mm 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 hip replacement cups made of crosslinked polyethylene. The recall is because sterilant used in production might cause tissue reactions, though no injuries have been reported.
Sterilant (hydrogen peroxide) used during manufacturing might leave harmful residues in the hip cup. This could potentially cause tissue reactions, though the exact risk is not confirmed.
People who own or use Zimmer Biomet hip replacement cups with the specific model and size (32mm internal diameter, 53mm outer diameter) are affected. Those with hip replacements are most at risk.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene', size 32mm internal diameter and 53mm outer diameter. All production lots are affected.
Identify your hip cup model and size to confirm if it matches the recalled units (32mm internal diameter, 53mm outer diameter).
The recall states there is a potential for adverse tissue reactions but cannot rule out the risk. No injuries have been reported.
Check if your hip cup is labeled as 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 32 mm, O.D. 53 mm'. All production 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-0340-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0340-2021 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.
