Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. Affected units include specific size and lot numbers. 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 replacement cups made from crosslinked polyethylene that may have untested sterilant causing tissue reactions. This could lead to adverse reactions in patients using the implants.
The sterilant used in the hip cup component wasn't tested for biocompatibility. This could cause tissue reactions, but the exact risk isn't confirmed.
Patients with Zimmer Biomet hip cups of the specified size and lot numbers are affected. Those with recent hip replacements are at higher risk.
Check for the specific cup model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm internal diameter, 47 mm outer diameter with spacers. All lots of this item are affected.
Reach out to Zimmer Biomet for return instructions as the remedy is not specified in the recall.
The recall states there's a potential for adverse tissue reactions but cannot rule out the risk. The exact danger level isn't confirmed.
Check for the specific model: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, 22 mm internal diameter, 47 mm outer diameter with spacers. All lots of this item are affected.
The recall does not specify a remedy. Contact Zimmer Biomet directly for return 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-0326-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0326-2021 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.
