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 Prosthesis models because the labels and instructions list an incorrect metal coating material symbol. This labeling error could lead to confusion about the implant's composition, but it does not pose a direct safety risk to users.
The recall involves incorrect labeling of the metal coating material symbol on the implant's box and inner pouch labels, as well as the instructions for use. This error could cause confusion about the implant's composition but does not indicate a risk of injury or malfunction during normal use.
Patients who received the recalled Talar Dome Total Ankle Prosthesis models (Sloped, Size 0, Right) from Integra LifeSciences. Those most at risk are individuals with the specific product numbers listed in the recall.
Check if your Talar Dome Total Ankle Prosthesis is Sloped, Size 0, Right, with Product Numbers LJV180T (182853, 182854, 183344). The recall applies to specific models sold by Integra LifeSciences.
Reach out to Integra LifeSciences directly for details about the recall and next steps.
No, the recall is for labeling errors that do not pose a safety risk. The incorrect metal coating symbol does not affect the implant's function or safety.
Contact Integra LifeSciences directly for details about the recall and next steps.
The affected models are Talar Dome Total Ankle Prosthesis, Sloped, Size 0, Right, with Product Numbers LJV180T (182853, 182854, 183344).
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1168-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1168-2019 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.
