Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units include specific model and all lots.
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 risks of adverse tissue reactions from residual sterilant. This could affect patients who received the specific cup model.
The hip cup component was sterilized with hydrogen peroxide, but the residual sterilant's biocompatibility wasn't confirmed. This could potentially cause adverse tissue reactions in some patients.
Patients who received the recalled hip cup model are most at risk. The recall affects all units of this specific cup design.
The recalled cup has a specific model ID: 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm. All lots of this model are affected.
Identify if your hip cup matches the model ID: 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm.
The recall states there is a potential for adverse tissue reactions but cannot rule out the risk. The exact danger level is not confirmed.
Check if your hip cup has the model ID: 32 mm, 10 degree inclined face, O.D. Cup with Spacers, 61 mm. All lots of this model are affected.
The recall does not specify a remedy, so 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-0390-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0390-2021 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.
