Howmedica Osteonics recalls Triathlon Tibial Insert model X3 POLY 16 MM due to potential packaging breaches that could compromise sterility.
Potential packaging breaches of inner blister and outer sterile blister.
Howmedica Osteonics is recalling their Triathlon Tibial Insert model X3 POLY 16 MM because the packaging might not seal properly. This could lead to contamination or infection if the device is used without proper sterility.
The packaging may breach, allowing contaminants to enter the sterile device. This could cause infection if the device is used without proper sterility during medical procedures.
Athletes using the Triathlon Tibial Insert model X3 POLY 16 MM for running or cycling. Those with medical implants or injuries may be at higher risk due to potential infection.
Check for the model name 'X3 POLY 16 MM' on the packaging. The product was sold with part number 5537-G-513-E and lot numbers 9M3A91 or EV0DV0.
Inspect the inner and outer sterile blisters for any signs of damage or leaks.
The recall states potential packaging breaches could compromise sterility, but the product is not inherently unsafe if properly packaged. Consult your healthcare provider for guidance.
Look for the model name 'X3 POLY 16 MM' on the packaging, part number 5537-G-513-E, and lot numbers 9M3A91 or EV0DV0.
The recall does not specify a remedy, so check the packaging for damage 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-1266-2024 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-1266-2024 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.
