Zimmer Biomet recalls hip replacement cups due to unconfirmed risk of adverse tissue reactions from residual sterilant. Affected units: all lots of 32mm polyethylene cups with specific ID.
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 made of polyethylene that may contain unconfirmed residual sterilant. This could potentially cause adverse tissue reactions, though the risk is not yet confirmed to be serious.
The hip cup was sterilized using hydrogen peroxide, but the record does not confirm whether the remaining sterilant is safe for body tissue. This could potentially cause adverse reactions like inflammation or tissue damage.
People who have received this specific hip cup model for joint replacement surgery are affected. Patients with this implant are at risk if the residual sterilant causes tissue reactions.
Check if your hip cup has the ID number 32 mm, model 00-8065-958-32, and is part of the All Poly Acetabular Cup Longevity Crosslinked Polyethylene series. All lots of this specific cup are affected.
Reach out to Zimmer Biomet directly to confirm if your hip cup is affected and get guidance on next steps.
The recall states there is a potential for adverse tissue reactions but cannot confirm if this risk is serious or likely to occur.
Check if your hip cup has the ID number 32 mm, model 00-8065-958-32, and is part of the All Poly Acetabular Cup Longevity Crosslinked Polyethylene series. All lots of this specific cup are affected.
Contact Zimmer Biomet directly to confirm if your hip cup is affected and get guidance on 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-0397-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0397-2021 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.
