Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis (Sloped, Size 0, Left) 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 type of ankle prosthesis because the labels and instructions incorrectly list the metal coating material. This labeling error could lead to confusion during implant procedures, but it does not pose an immediate safety risk to users.
The implant labels and instructions incorrectly list the metal coating material symbol. This labeling error could cause confusion during surgical procedures or implant adjustments, but it does not involve a physical hazard like injury or malfunction.
Patients with the specific Talar Dome Total Ankle Prosthesis (Sloped, Size 0, Left) model are affected. Those who have undergone ankle replacement surgery with this model are most at risk.
Check for the product name 'Talar Dome Total Ankle Prosthesis', model 'Sloped, Size 0, Left', and product number 'LJV190T'. 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, this recall is for labeling errors that could cause confusion during procedures but does not pose an immediate safety risk.
Check for the product name 'Talar Dome Total Ankle Prosthesis', model 'Sloped, Size 0, Left', and product number 'LJV190T' on your implant labels or instructions.
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-1172-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1172-2019 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.
