Howmedica Osteonics recalls Triathlon Tibial Insert model X3 POLY 11 MM due to potential packaging breaches that could compromise sterility during surgery.
Potential packaging breaches of inner blister and outer sterile blister.
Howmedica Osteonics is recalling its Triathlon Tibial Insert model X3 POLY 11 MM because the packaging might not seal properly. This could lead to unsterile surgical implants, which is a serious risk for patients undergoing surgery.
The packaging may breach, allowing contaminants to enter the sterile surgical environment. This could lead to infections or other complications during surgery if the implant is not properly sterilized.
Surgical patients and healthcare providers who use this specific implant model. Those with the model number X3 POLY 11 MM are most at risk.
Check for the model name 'X3 POLY 11 MM' on the packaging. The product has a specific lot number (EP81Y7, YL5VKA) and expiration date of October 2028.
Immediately stop using the Triathlon Tibial Insert model X3 POLY 11 MM if it is part of the recall.
No, the packaging may breach, which could compromise sterility during surgery. Do not use this product.
Stop using it immediately and contact Howmedica Osteonics for further instructions.
Look for the model name 'X3 POLY 11 MM' on the packaging, along with lot numbers EP81Y7 or YL5VKA and expiration date 10/07/2028.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1263-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1263-2024 from Howmedica. 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.