Integra LifeSciences recalls Salto Talaris ankle prosthesis trays with incorrect metal coating labels. Affected units may have safety labeling errors that could impact surgical procedures.
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 specific Salto Talaris ankle prosthesis trays due to incorrect metal coating labels on the product packaging and instructions. This labeling error could potentially impact surgical procedures if the wrong material is used during implantation.
The recall involves incorrect labeling of the metal coating material on the implant trays. This could lead to confusion during surgical procedures if the wrong material is used, potentially affecting the implant's compatibility or safety.
Patients who received the recalled Salto Talaris ankle prosthesis trays during surgery are likely affected. Surgeons and medical staff using these specific trays for procedures are at higher risk.
Check for the part number LJU200T on the Salto Talaris ankle prosthesis tray. The affected units were sold with specific serial numbers: 180072, 181145, 184085, 184086.
Look for the part number LJU200T on the Salto Talaris ankle prosthesis tray and verify the serial numbers 180072, 181145, 184085, or 184086.
The recall is due to incorrect labeling of the metal coating material on the implant trays, which could impact surgical procedures if the wrong material is used.
Check the product labels for the part number LJU200T and serial numbers 180072, 181145, 184085, or 184086. If you have the recalled item, contact Integra LifeSciences for further instructions.
The recall indicates a labeling error that could impact surgical procedures, but there is no indication of immediate injury risk to patients or users.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1150-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1150-2019 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.
