Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis with incorrect metal coating labeling on implant labels and instructions. Affected units may have safety risks.
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 ankle prosthesis model due to incorrect metal coating labeling on the product labels and instructions. This labeling error could lead to confusion about the implant's material composition.
The implant labels and instructions incorrectly list the metal coating material symbol. This could cause confusion about the implant's composition, potentially leading to incorrect usage or misunderstandings about the implant's properties.
Patients who received the Talar Dome Total Ankle Prosthesis, Sloped, Size 3, Right, Product No. LJV183T are likely affected. Those with this specific implant are at risk of confusion about the metal coating material.
Check for the product name 'Talar Dome Total Ankle Prosthesis', size 3, right leg, and product number LJV183T. The recall covers specific units sold between 182859 and 183348.
Look for the product name, size, and product number on the implant label and instructions.
The recall is for labeling errors that could cause confusion about the metal coating material, but it does not pose a direct safety risk.
Check the product label and instructions for the specific model and product number. Contact Integra LifeSciences for further guidance.
Verify the product name 'Talar Dome Total Ankle Prosthesis', size 3, right leg, and product number LJV183T.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1171-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1171-2019 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.
