Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis with incorrect metal coating labeling on implant labels and instructions. Affected units may have safety risks due to labeling errors.
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 type of ankle prosthesis due to incorrect metal coating labeling on the product's labels and instructions. This labeling error could lead to confusion about the implant's material, potentially affecting medical safety.
The labeling error shows an incorrect metal coating material symbol on the implant's box and inner pouch labels, as well as the instructions for use. This could cause confusion about the implant's material composition, which might impact medical decisions or safety.
Patients who own or use the recalled Talar Dome Total Ankle Prosthesis (Sloped, Size 3, Left) are affected. Medical professionals who have this implant in their patients are at higher risk due to potential labeling confusion.
Check for the product name 'Talar Dome Total Ankle Prosthesis', sloped size 3, left leg, and product numbers LJV193T (182863, 182864, 183354).
Look for the product name, size, and product numbers on the implant's box and inner pouch.
The recall is due to incorrect metal coating material symbols on the implant labels and instructions, which could cause confusion about the implant's material.
The official recall notice does not specify a remedy, so check the product labels and contact Integra LifeSciences for further guidance.
The recall does not mention any risk of serious injury; the hazard is limited to labeling confusion.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1175-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1175-2019 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.
