Integra LifeSciences recalls Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T due to incorrect metal coating labeling on implant labels and instructions. Affected users should contact Integra 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 a specific ankle prosthesis tray and talar dome part due to incorrect metal coating labeling on the product's labels and instructions. This labeling error could lead to confusion about the metal coating material, but it does not pose an immediate safety risk to users.
The recall involves incorrect labeling of the metal coating material on the implant's box and inner pouch labels, as well as the instructions for use. This error could cause confusion about the metal coating material, but it does not involve a physical hazard that could cause injury or damage.
Patients who own or use the specific Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T are affected. Those with this exact part number are most at risk of receiving incorrect labeling information.
Check for the Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T. The product was sold under the part number LJU201T.
Reach out to Integra LifeSciences for specific guidance on the recalled part and next steps.
No, the recall is for labeling errors that could cause confusion about the metal coating material, but it does not pose an immediate safety risk.
Contact Integra LifeSciences for specific guidance on the recalled part and next steps.
Check for the Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part No. LJU201T.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1151-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1151-2019 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.
