Integra LifeSciences recalls specific Salto Talar: incorrect metal coating symbol on labels may cause confusion during implant procedures. Affected patients should contact 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 left ankle prosthesis tray due to incorrect metal coating labeling on the product. This could lead to confusion during surgical procedures if the wrong material is used.
The implant labels incorrectly show a metal coating symbol. This could cause confusion during surgery if the wrong material is used, potentially affecting the procedure's safety.
Patients with the recalled left ankle prosthesis tray (Size 1, Part No. LJU211T) are affected. Surgeons and medical teams using this specific implant are at highest risk.
Check for the Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T. The product was sold under the manufacturer Integra LifeSciences.
Reach out to Integra LifeSciences for specific guidance on the recalled item.
The recall is for labeling errors that could cause confusion during surgery, but it does not pose an immediate risk to patients using the implant.
Contact Integra LifeSciences directly for details about the recalled item.
Look for the specific model: Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, Part No. LJU211T.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1155-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1155-2019 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.