Howmedica Osteonics recalls Triathlon Tibial Insert model X3 POLY 16 MM due to potential packaging breaches that could compromise sterility during use.
Potential packaging breaches of inner blister and outer sterile blister.
Howmedica Osteonics is recalling its Triathlon Tibial Insert model X3 POLY 16 MM because the packaging might not seal properly, risking contamination. This could lead to infection or other complications if the device is used without proper sterility.
The packaging may have breaches in the inner blister and outer sterile blister. This could allow contamination of the device, increasing the risk of infection or other complications during use.
Users of the Triathlon Tibial Insert model X3 POLY 16 MM are affected. Athletes and medical professionals who use this device for tibial support are most at risk due to potential contamination.
Check for the model name 'X3 POLY 16 MM' on the packaging. The product has a lot number (H21A0K, XY776E) and expiration date of 10/07/2028.
Inspect the inner and outer blisters for any signs of damage or breaches.
The recall is due to potential packaging breaches that could compromise sterility, so it is not recommended for use until the issue is resolved.
Look for the model name 'X3 POLY 16 MM' on the packaging, with lot numbers H21A0K or XY776E and expiration date 10/07/2028.
Check the packaging for breaches in the inner and outer blisters. If found, stop using it and contact Howmedica Osteonics for further instructions.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-1265-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1265-2024 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.
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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.
