Zimmer Biomet recalls hip replacement cups with unconfirmed sterilant biocompatibility risks. Affected units may cause tissue reactions; contact for return or repair.
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 unconfirmed sterilant risks. This could potentially cause tissue reactions, so affected users should contact the company for next steps.
The sterilant used in the hip cup wasn't tested to ensure it won't cause tissue reactions. This means there's a potential risk of adverse reactions in the body.
People who received this specific hip cup model for joint replacement surgery are affected. Those with the cup implanted in their hip are at highest 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, 49 mm'. All lots of this product are affected.
Reach out to Zimmer Biomet directly to confirm if your hip cup is affected and get instructions for next steps.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the risk. The exact danger level isn't specified in the notice.
Check if your hip cup matches the model name and all lots listed in the recall notice.
Contact Zimmer Biomet directly to confirm if your hip cup is affected and get instructions for 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-0391-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0391-2021 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.
