Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis with incorrect metal coating labeling on labels and instructions. Affected units may have safety risks due to labeling errors.
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 product labels and instructions. This labeling error could lead to confusion about the implant's material, potentially affecting patient safety during medical procedures.
The labeling error shows an incorrect symbol for the metal coating material on the implant's box and inner pouch. This could cause confusion about the implant's composition, which might impact surgical procedures or post-operative care if the wrong material is assumed.
Patients who own or use the recalled Talar Dome Total Ankle Prosthesis (Sloped, Size 1, Left) are affected. Medical professionals who have this implant in their patients are at higher risk due to potential labeling confusion.
Check for the product name 'Talar Dome Total Ankle Prosthesis', sloped size 1, left leg, and product numbers 182860, 182861, 183350, or 183351. The error is in the metal coating labeling on the box and inner pouch.
Look for the product name 'Talar Dome Total Ankle Prosthesis', sloped size 1, left leg, and product numbers 182860, 182861, 183350, or 183351.
The recall is for labeling errors, not a safety hazard. The risk is low as it only affects the metal coating symbol on labels and instructions, not the implant's function.
No, the recall does not require stopping use. The issue is labeling, not the implant's safety.
Check the product name, size, leg, and product numbers on the box and inner pouch. Affected units have specific numbers: 182860, 182861, 183350, or 183351.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1173-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1173-2019 from Integra. 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.
