Integra LifeSciences recalls Tibial Total Ankle Prosthesis Tray, Size 1 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 LifeSciences is recalling their Tibial Total Ankle Prosthesis Tray, Size 1 because the metal coating labeling on the implant labels and instructions is incorrect. This could potentially lead to confusion about the implant's material, though the recall does not specify immediate safety risks.
The implant labels and instructions incorrectly list the metallic coating material symbol. This could cause confusion about the implant's material composition, but the recall does not indicate a direct safety risk in normal use.
Patients who have received the Tibial Total Ankle Prosthesis Tray, Size 1 (Product No. LJU221T) from Integra LifeSciences are likely affected. Those with the specific product model and serial numbers listed in the recall are at risk.
Check for the product name 'Tibial Total Ankle Prosthesis Tray, Size 1' with Product Number LJU221T. The affected units have specific serial numbers listed in the recall: 180750, 180860, 180861, 180892, 181432.
Look for the Product Number LJU221T on the implant label or packaging.
The recall states there is an incorrect metal coating labeling on the implant labels and instructions, but it does not mention any immediate safety risks.
The recall does not specify a remedy, so you should check the product label for the Product Number LJU221T to confirm if it is affected.
Check the product label for the Product Number LJU221T and serial numbers 180750, 180860, 180861, 180892, or 181432.
We’ve drafted a message you can send Integra to request your refund or repair — edit it as you like.
Subject: Recall Z-1159-2019 — Integra Integra Hello, I own a Integra that is covered by recall Z-1159-2019 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.
