Zimmer Biomet recalls hip prosthetic cups made with untested sterilant that may cause tissue reactions. Affected units include specific model and all lots. 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 causing tissue reactions. This could lead to adverse reactions in patients using the device.
The sterilant (hydrogen peroxide) used in the hip cup was not tested for biocompatibility. This could lead to adverse tissue reactions if the residual sterilant causes an immune response.
Patients with Zimmer Biomet hip cups of this specific model and all lots are affected. Those with the recalled cup are at risk of tissue reactions.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm ID, 59 mm OD with spacers. All lots of this specific product number (00-8065-556-32) are affected.
Reach out to Zimmer Biomet for specific return instructions as the remedy is not stated in the recall.
The recall states the sterilant may cause adverse tissue reactions, but the exact risk level is not specified.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm ID, 59 mm OD with spacers. All lots of product number 00-8065-556-32 are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly for instructions.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0352-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0352-2021 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.
