Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. 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 untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the implants.
The hip cup used hydrogen peroxide for sterilization, but the residual sterilant wasn't tested for biocompatibility. This could cause tissue reactions in the body.
Patients with Zimmer Biomet hip cups from the specified model and all lots are affected. Those with recent implants are at higher risk.
Check for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm ID, 57 mm OD with spacers. All lots are affected.
Identify the model and lot number from the product description.
This recall applies to specific Zimmer Biomet hip cups with the model number mentioned. Check your implant details to see if you are affected.
The recall does not specify a remedy, so contact Zimmer Biomet directly for guidance.
Look for the model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 32 mm ID, 57 mm OD with spacers. All lots are affected.
We’ve drafted a message you can send Zimmer Biomet to request your refund or repair — edit it as you like.
Subject: Recall Z-0348-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0348-2021 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.
