Integra LifeSciences recalls specific Salto Talaris ankle prosthesis trays due to incorrect metal coating labeling on implant labels and instructions. Affected patients should contact 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 ankle prosthesis tray model because its labeling incorrectly lists the metal coating material. This could lead to confusion during implant procedures, though it does not pose an immediate safety risk.
The implant labels and instructions incorrectly list the metal coating material symbol. This could cause confusion during surgical procedures if the wrong material is used, potentially affecting the implant's compatibility or safety.
Patients with the recalled Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T. Orthopedic surgeons and medical staff using this model are most at risk of mislabeling during surgery.
Check for the specific part number LJU202T on the tray's box and inner pouch. The product was sold in the U.S. with serial numbers 180073, 181259, and 182899.
Reach out to Integra LifeSciences for specific instructions on how to handle the recalled item.
No, the recall is for labeling accuracy, not a safety hazard. The incorrect metal coating symbol does not pose an immediate risk to patients.
Contact Integra LifeSciences directly for guidance on handling the recalled item.
Check for part number LJU202T on the tray's box and inner pouch. The product was sold with serial numbers 180073, 181259, and 182899.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1152-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1152-2019 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.
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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.
