Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis with incorrect metal coating labeling on implant 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 LifeSc: Talar Dome Total Ankle Prosthesis (Flat Cut, Size 1, Right) is recalled because the metal coating labels have an incorrect symbol. This labeling error could lead to confusion about the implant's material, potentially affecting surgical safety.
The implant labels and instructions (IFU) list an incorrect metallic coating material symbol. This error could cause confusion about the implant's material composition, which might impact surgical procedures or post-operative care if the wrong material is used.
Patients who received the Talar Dome Total Ankle Prosthesis with the specific product number (LJU811T) are affected. Surgeons and medical staff who handled these implants during procedures are at higher risk due to potential labeling confusion.
Check for the product number LJU811T on the implant label or packaging. The affected units include specific model numbers: 180076, 180082, and 185085.
Look for the product number LJU811T on the implant label or packaging.
The recall is for labeling errors, not a safety hazard. The risk is low as it does not affect the implant's function or safety directly.
Check for the product number LJU811T on the implant label or packaging. Affected units include model numbers 180076, 180082, and 185085.
The recall does not require immediate action. Check the product label to confirm if your implant is affected.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1165-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1165-2019 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.
