Zimmer Biomet recalls hip prosthetic cups due to potential adverse tissue reactions from untested sterilant residue. Affected units include specific size and model. 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 prosthetic cups that may have untested sterilant residue, potentially causing tissue reactions. This affects patients with the specific cup model and size listed in the recall notice.
The sterilant (hydrogen peroxide) used during manufacturing wasn't fully tested for biocompatibility. This could lead to adverse tissue reactions, though the risk is not confirmed to be serious.
Patients who received the recalled hip cup model (ID 26 mm, O.D. 59 mm) are most at risk. The recall applies to all units produced under the specific lot number.
Check if your hip cup has the model ID 26 mm, O.D. 59 mm with spacers. The recall covers all units with the lot number 00-8065-556-26.
Identify if your hip cup matches the model ID 26 mm, O.D. 59 mm with spacers and lot number 00-8065-556-26.
The recall states there's a potential for adverse tissue reactions, but it cannot rule out serious injury. The risk is not confirmed to be serious.
Check if your hip cup has the model ID 26 mm, O.D. 59 mm with spacers and lot number 00-8065-556-26.
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-0350-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0350-2021 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.
