Zimmer Biomet recalls hip replacement cups due to unconfirmed sterilant biocompatibility. 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 cause tissue reactions due to untested sterilant residue. This could lead to adverse reactions in patients using the implants.
The hip cup was sterilized using hydrogen peroxide, but the remaining sterilant wasn't tested for biocompatibility. This could cause tissue reactions in some patients.
Patients with Zimmer Biomet hip cups from the recalled model are affected. Those with the specific cup design and size are most at risk.
Check for the cup model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm, 10 degree inclined face, 49 mm. All lots are affected.
Reach out to Zimmer Biomet for specific return instructions as the recall remedy is not stated.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. This is not confirmed to cause serious injury.
Check for the specific model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm, 10 degree inclined face, 49 mm. All lots are affected.
The recall remedy is not stated, so contact Zimmer Biomet directly for instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0363-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0363-2021 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.
