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 left 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 implant labels contain an incorrect symbol for the metal coating material. This could lead to confusion during surgery if the wrong material is used, potentially affecting the procedure's outcome.
Orthopedic surgeons and patients who have the specific left ankle prosthesis tray model (Size 0, Part No. LJU210T) are affected. Patients with this implant are at risk if the incorrect labeling causes surgical confusion.
Check for the product name 'Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Left' and part number LJU210T. The recall covers specific serial numbers: 180074, 181260, 182901, 184538.
Look for the part number LJU210T and serial numbers 180074, 181260, 182901, or 184538 on the implant labels.
The recall is for labeling errors that could cause confusion during surgery, but it does not pose an immediate risk to patients using the implant.
Check the product labels for the part number and serial numbers listed in the recall. If you have the specific model, contact Integra LifeSciences for further instructions.
Look for the part number LJU210T and serial numbers 180074, 181260, 182901, or 184538 on the implant labels.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1154-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1154-2019 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.
