Integra LifeSciences recalls specific Talar Dome Total Ankle Prosthesis models due to incorrect metal coating labeling on implant labels and instructions. Affected patients should contact the company 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 left ankle prosthesis model because the metal coating labels contain an incorrect symbol. This labeling error could lead to confusion about the implant's material, but it does not pose an immediate safety risk to users.
The implant labels and instructions (IFU) list an incorrect metallic coating material symbol. This error could cause confusion about the implant's material composition, but it does not involve a physical hazard like injury or malfunction in normal use.
Patients with the recalled Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T are affected. Those with this specific implant model are most at risk due to potential labeling confusion.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 1, left leg, and product number LJU821T. This specific model was sold in the U.S. and is part of the recall.
Reach out to Integra LifeSciences for specific guidance on the recalled product and next steps.
No, the recall is for labeling errors that do not pose a safety risk. The incorrect symbol does not cause injury or malfunction in normal use.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 1, left leg, and product number LJU821T.
Contact Integra LifeSciences directly for specific guidance on the recalled product and next steps.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1162-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1162-2019 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.
