Integra LifeSciences recalls Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T due to incorrect metallic coating material symbol on labels and IFU.
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 size of ankle prosthesis tray because the labels and instructions list an incorrect metallic coating material symbol. This could lead to confusion about the implant's composition, but it does not pose an immediate safety risk to users.
The labels and instructions for the implant incorrectly list a metallic coating material symbol. This could cause confusion about the implant's composition, but it does not involve a physical hazard like injury or malfunction.
Patients who received the recalled Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T from Integra LifeSciences are affected. Those with this specific implant are most at risk due to potential labeling confusion.
Check for the product number LJU222T on the tray or packaging. The recalled item is a Tibial Total Ankle Prosthesis Tray, Size 2, sold in specific batch ranges.
Review the metallic coating material symbol on the implant labels and instructions for accuracy.
No, the recall is for labeling accuracy only and does not pose a safety risk to users.
Check the labels and instructions for the correct metallic coating material symbol; no action is needed if the symbol matches the intended material.
The recalled product is the Tibial Total Ankle Prosthesis Tray, Size 2, Product No. LJU222T, with specific batch numbers listed in the recall notice.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1160-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1160-2019 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.
