Zimmer Biomet recalls hip replacement cups due to unconfirmed risks from residual sterilant. Owners should contact for details.
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 polyethylene material. The recall is because the sterilant used in production might cause tissue reactions, though no injuries have been reported.
The sterilant (hydrogen peroxide) used during manufacturing wasn't fully tested for safety. This could potentially cause tissue reactions, but no injuries have been reported.
People who received this hip cup replacement from Zimmer Biomet. Those with the specific cup model and lot numbers are most at risk.
Check for the cup model: ZCA All Poly Acetab: 28 mm, Neutral, O.D. Cup with Spacers, 51 mm. All lots are affected.
Reach out to Zimmer Biomet for specific instructions on what to do with the recalled cup.
The recall states there's a potential for tissue reactions but no injuries have been reported. The risk is unconfirmed.
Check for the cup model: ZCA All Poly Acetabular Cup, 28 mm, Neutral, O.D. Cup with Spacers, 51 mm. All lots are affected.
Contact Zimmer Biomet for specific instructions on what to do with the recalled cup.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0335-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0335-2021 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.
