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 manufacturer 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 incorrectly list the metal coating material. This labeling error could lead to confusion during implant procedures, though it does not pose an immediate safety risk to patients.
The implant labels and instructions incorrectly list the metal coating material symbol. This labeling error could cause confusion during surgical procedures or implant adjustments, potentially leading to incorrect material selection.
Patients with the specific Talar Dome Total Ankle Prosthesis models listed (Sloped, Size 1, Right) are affected. Those who have undergone ankle replacement surgery with these models are most at risk.
Check for the product name 'Talar Dome Total Ankle Prosthesis', model 'Sloped, Size 1, Right', and product number LJV181T (or similar numbers 182855, 182856, 183397).
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 surgery, not an immediate safety risk.
Contact Integra LifeSciences directly for details about the recalled product and next steps.
Check for the product name 'Talar Dome Total Ankle Prosthesis', model 'Sloped, Size 1, Right', and product numbers 182855, 182856, or 183397.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1169-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1169-2019 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
