Integra LifeSciences recalls specific Talar Dome Total Ankle Prostheses due to 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 certain Talar Dome Total Ankle Prostheses because the labels and instructions list an incorrect metal coating material symbol. This could lead to confusion about the implant's composition, though serious injury risks are not described in the recall.
The recall involves incorrect labeling of the metal coating material on the implant's box and inner pouch. This could cause confusion about the implant's composition, but the recall does not mention any immediate safety risks or injuries.
Patients who received the specific Talar Dome Total Ankle Prostheses (Flat Cut, Size 3, Right) with Product No. LJU813T are affected. Those with the implant are most at risk due to potential labeling confusion.
Check for the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right with Product No. LJU813T. The product was sold with serial numbers 180078, 182903, 183670, and 190799.
Review the metal coating material symbol on the implant's box and inner pouch labels for accuracy.
The recall does not describe any safety risks or injuries. The issue is labeling confusion, not a physical hazard.
Check for the Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right with Product No. LJU813T and serial numbers 180078, 182903, 183670, or 190799.
The recall does not specify a remedy. Check the labeling for accuracy, but no action is required beyond this review.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1167-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1167-2019 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.
