Integra LifeSciences recalls specific Talar Dome Total Ankle Prostheses due to incorrect metal coating labeling on implants. This may lead to confusion in surgical procedures. Affected units include model LJU822T, size 2 left leg.
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 specific Talar Dome Total Ankle Prostheses (left leg, size 2) because the metal coating labels have incorrect symbols. This could cause confusion during surgery if the wrong material is used.
The implant labels contain incorrect symbols for the metal coating material. This could lead to confusion about which metal is used during surgery, potentially causing the wrong material to be selected. However, this is a labeling issue rather than a physical defect.
Patients who received the recalled Talar Dome Total Ankle Prostheses (left leg, size 2) are affected. Surgeons and medical staff handling these specific implants may also be at risk during procedures.
Check for the product number LJU822T, size 2, left leg in the Talar Dome Total Ankle Prosthesis. The recall covers specific serial numbers: 180080, 182904, 183671, 184878.
Verify the product number, size, and leg side on your implant label or packaging.
The recall is due to incorrect metal coating material symbols on the implant labels, which could cause confusion during surgical procedures.
No, this is a labeling issue that does not require immediate removal. The recall is for information purposes to prevent potential confusion during surgery.
Check for the product number LJU822T, size 2, left leg, and serial numbers 180080, 182904, 183671, or 184878.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1163-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1163-2019 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.
