Integra LifeSciences recalls specific Salto Talar: incorrect metal coating symbol on labels may cause confusion during implant 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 a specific ankle prosthesis tray due to incorrect metal coating labeling on the product. This could lead to confusion during surgical procedures if the wrong material is used.
The labels on the prosthesis tray and its instructions list an incorrect metal coating symbol. This could cause confusion during surgery if the wrong material is used, potentially leading to incorrect implant selection.
Orthopedic surgeons and patients who have the specific Salto Talaris ankle prosthesis tray model (Part No. LJU203T) are affected. Patients using this implant are at risk of surgical confusion.
Check for the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T. The product was sold between 181155 and 182900.
Look for the correct metal coating symbol on the product labels and instructions.
The recall is for labeling accuracy, not a safety hazard. The risk is low as it only affects labeling during surgical procedures.
Check for the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, Part No. LJU203T. The product was sold between 181155 and 182900.
Check the product labels for the correct metal coating symbol. If the symbol is incorrect, contact Integra LifeSciences for guidance.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1153-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1153-2019 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.
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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.
