Integra LifeSciences recalls specific Salto Talaris ankle prosthesis trays due to incorrect metal coating labeling on implant labels and instructions. 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 model due to incorrect metal coating labeling on the implant labels and instructions. This could lead to confusion during surgical procedures if the wrong material is used.
The implant labels and instructions list an incorrect metallic coating material symbol. This could cause confusion during surgical procedures if the wrong material is used, potentially affecting the implant's compatibility or function.
Patients with the specific left ankle prosthesis tray model (Size 2, Part No. LJU212T) are affected. Surgeons and medical staff using the product are at risk of using incorrect labeling during procedures.
Check for the specific model: Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T. The product was sold in the U.S. between 2018 and 2020.
Reach out to Integra LifeSciences for specific instructions on how to handle the recalled item.
The recall is for incorrect labeling on implant labels and instructions, which could cause confusion during surgical procedures. It is not immediately dangerous but requires attention.
Check for the specific model: Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, Part No. LJU212T. The product was sold in the U.S. between 2018 and 2020.
Contact Integra LifeSciences for specific instructions on how to handle the recalled item.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1156-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1156-2019 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.
