Integra LifeSciences recalls Tibial Total Ankle Prosthesis Tray Size 0 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 LifeSc: Tibial Total Ankle Prosthesis Tray Size 0 is recalled because its labeling incorrectly lists the metal coating material. This could lead to improper implant selection and potential complications during surgery.
The labeling error shows an incorrect metal coating material symbol on the implant's box and inner pouch. This could cause surgeons to select the wrong implant material, potentially leading to complications during surgery.
Patients with the recalled Tibial Total Ankle Prosthesis Tray Size 0 (Product No. LJU220T) are affected. Surgeons and medical staff who use this implant are at higher risk during surgical procedures.
Check for the product name 'Tibial Total Ankle Prosthesis Tray, Size 0' with Product Number LJU220T. This item was sold under Integra LifeSciences.
Reach out to Integra LifeSciences for specific guidance on the recalled product.
The recall is for labeling errors that could lead to improper implant selection during surgery, but it does not pose an immediate risk to patients already using the product.
Check for the product name 'Tibial Total Ankle Prosthesis Tray, Size 0' with Product Number LJU220T.
Contact Integra LifeSciences for specific guidance on the recalled product.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1158-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1158-2019 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.
