Zimmer Biomet recalls hip replacement cups made with untested sterilant that may cause tissue reactions. Affected units have specific dimensions 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 hip cup component was sterilized using hydrogen peroxide, but the residual sterilant was not tested for biocompatibility. This could potentially cause adverse tissue reactions in the body, such as inflammation or rejection.
Patients with Zimmer Biomet hip replacement cups made from crosslinked polyethylene with specific dimensions (ID 22mm, OD 49mm) are affected. Those who have received the recalled cup implant are most at risk.
Check for the product name: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, ID 22 mm, Neutral, O.D. Cup with Spacers, 49 mm. All lots of this specific item are affected.
Zimmer Biomet has not provided specific return instructions in the recall notice.
The recall states there is a potential for adverse tissue reactions, but Zimmer Biomet cannot rule out this risk. The exact danger level is not specified in the notice.
Check for the specific product name and dimensions: ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, ID 22 mm, Neutral, O.D. Cup with Spacers, 49 mm. All lots of this item are affected.
Zimmer Biomet has not provided specific return instructions in the recall notice. Contact the manufacturer 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-0329-2021 — Zimmer Biomet Zimmer Biomet Hello, I own a Zimmer Biomet that is covered by recall Z-0329-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
