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 LifeSc: Talar Dome Total Ankle Prostheses with Flat Cut, Size 3, Left, Product No. LJU823T are recalled because the metal coating labels contain an incorrect symbol. This labeling error could lead to confusion about the implant's material, potentially affecting surgical outcomes.
The implant labels and instructions (IFU) list an incorrect metallic coating material symbol. This error could cause confusion about the metal composition, which might impact surgical decisions or implant compatibility during procedures.
Patients who received the specific Talar Dome Total Ankle Prosthesis model (Flat Cut, Size 3, Left, Product No. LJU823T) from Integra LifeSciences are affected. Surgeons and medical staff who used this model during procedures are at higher risk.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 3, left leg, and product number LJU823T on the implant or packaging. The recall covers specific units sold with this exact model.
Verify the product name, flat cut, size 3, left leg, and product number LJU823T on the implant or packaging.
The recall is due to incorrect metallic coating material symbols on the implant labels and instructions, which could cause confusion about the metal composition.
The official notice does not mention a fix or remedy for this labeling error.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 3, left leg, and product number LJU823T on the implant or packaging.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1164-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1164-2019 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.
