Zimmer Biomet recalls hip cups made with untested sterilant that may cause tissue reactions. Affected units include specific model and all lots. Contact for return or replacement.
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 cups that may have untested sterilant causing tissue reactions. This could lead to health issues if the sterilant reacts with body tissues.
The sterilant used in the hip cup was not tested for biocompatibility. This means the residual sterilant could potentially cause tissue reactions in the body, leading to health complications.
People who have received this specific hip cup model, typically those who had hip surgery using this product. Patients with the affected model are most at risk.
Check if your hip cup has the model number 00-8065-558-22 or the specific description: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm. All lots are affected.
Identify if your hip cup matches the model number 00-8065-558-22 or the specific description provided in the recall.
The recall states that the sterilant was not evaluated for biocompatibility, so there is a potential risk of tissue reactions. The product is not safe to use as recalled.
Check if your hip cup has the model number 00-8065-558-22 or the specific description: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 61 mm. All lots are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly for 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-0353-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0353-2021 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.
