Zimmer Biomet recalls hip replacement cups due to potential unconfirmed sterilant residue causing tissue reactions. Affected units include specific model numbers sold globally. Consumers 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 that may have unconfirmed sterilant residue. This could potentially cause tissue reactions, though the risk is not confirmed to be serious.
Sterilant (hydrogen peroxide) used in the cup was not properly tested for biocompatibility. This could lead to tissue reactions, but the risk is not confirmed to be serious.
Hip replacement patients who received the specific cup model (ID 28 mm, 10 degree inclined face) are affected. Patients with this implant are most at risk.
Check for the model number 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. : 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm'. All lots are affected.
Reach out to Zimmer Biomet for specific guidance on affected units and next steps.
The recall states there is a potential for tissue reactions but cannot rule out the risk. The severity is not confirmed to be serious.
Check for the model number 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 28 mm, 10 degree inclined face, O.D. Cup with Spacers, 51 mm'. All lots are affected.
Contact Zimmer Biomet directly for specific guidance on affected units and 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-0369-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0369-2021 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.
