Integra LifeSciences recalls Salto Talar: incorrect metal coating label on ankle prosthesis trays may cause confusion in implant labeling.
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 left ankle prosthesis tray model due to incorrect metal coating labeling on the implant. This labeling error could lead to confusion during surgical procedures, potentially affecting the implant's compatibility or safety.
The recall involves an incorrect metal coating material symbol on the implant labels. This error could cause confusion during surgical procedures, potentially affecting the implant's compatibility or safety. The labeling mistake may lead to improper implant selection or use.
Patients who received the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left, Part No. LJU213T from Integra LifeSciences are affected. Surgeons and medical staff who use this specific implant during procedures are at the highest risk.
Check for the product name 'Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left' and part number LJU213T. The recall covers specific units sold by Integra LifeSciences.
Verify the product name and part number to confirm if it matches the recalled item.
The recall is for labeling errors that could cause confusion during surgical procedures, but it does not pose a direct safety risk to patients in normal use.
Check for the product name 'Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Left' and part number LJU213T.
The recall does not specify a remedy, so you should check with Integra LifeSciences for further instructions.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1157-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1157-2019 from Integra LifeSciences. 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.
