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 certain Talar Dome Total Ankle Pro: Sloped, Size 2, Left, Product No. LJV192T. The recall is due to incorrect metal coating labeling on the implant labels and instructions, which could lead to confusion during medical procedures.
The implant labels and instructions list an incorrect metallic coating material symbol. This could cause confusion during medical procedures, but it does not pose a direct risk of injury or malfunction in normal use.
Patients with the specific Talar Dome Total Ankle Prosthesis model (Sloped, Size 2, Left, Product No. LJV192T) are affected. Those with the product are at risk of confusion during medical procedures due to incorrect labeling.
Check for the Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T. The product was sold with serial numbers 182862, 183352, and 183353.
Reach out to Integra LifeSciences for specific guidance on the recalled product.
The recall is due to incorrect labeling, which could cause confusion during medical procedures, but it does not pose a direct risk of injury or malfunction in normal use.
Contact Integra LifeSciences for specific guidance on the recalled product.
Check for the Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Left, Product No. LJV192T with serial numbers 182862, 183352, or 183353.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1174-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1174-2019 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.
