Zimmer Biomet recalls hip replacement cups made with untested sterilant that could cause tissue reactions. Affected units include specific cup models sold from 2017 onward.
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 untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the implants.
The hip cup component used hydrogen peroxide for sterilization, but the residual sterilant wasn't tested for biocompatibility. This could cause adverse tissue reactions in patients.
Patients with Zimmer Biomet hip cups from the specific model described in the recall are affected. Those with the recalled cup model are at risk of tissue reactions.
Check if your hip cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm' and item number 00-8065-544-26. All lots of this model are affected.
Look for the model name and item number on your hip cup to confirm if it's affected.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out the possibility. This is a low-risk hazard.
Check if your cup has the model name 'ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 26 mm, Neutral, O.D. Cup with Spacers, 47 mm' and item number 00-8065-544-26. All lots of this model are affected.
The recall does not specify a remedy, so you should 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-0327-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0327-2021 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.
