Integra LifeSciences recalls Tibial Total Ankle Prosthesis Tray Size 3 (Product No. LJU223T) due to incorrect metal coating labeling on implant labels and instructions. Affected patients should contact the company for details.
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
Integra LifeSciences is recalling a specific size of ankle prosthesis tray because the metal coating labels have incorrect symbols. This labeling error could lead to confusion about the implant's material, but it does not pose an immediate safety risk to users.
The implant labels and instructions (IFU) list an incorrect metallic coating material symbol. This error could cause confusion about the implant's material composition, but it does not involve a physical hazard like injury or malfunction during normal use.
Patients with the recalled Tibial Total Ankle Prosthesis Tray, Size : 3, Product No. LJU223T. Those who have this specific implant are most at risk due to potential labeling confusion.
Check for the product name 'Tibial Total Ankle Prosthesis Tray', size 3, and product number LJU223T. The recall covers units sold between 180894 and 181152.
Reach out to Integra LifeSciences for specific guidance on the recall and next steps.
No, the recall is for labeling errors that could cause confusion about the metal coating, but it does not pose a safety risk.
Contact Integra LifeSciences directly for instructions on the recall.
Check for the product name 'Tibial Total Ankle Prosthesis Tray', size 3, and product number LJU223T. The recall covers units sold between 180894 and 181152.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1161-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1161-2019 from Integra. 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.
