Integra LifeSciences recalls specific Talar Dome Total Ankle Prostheses 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 specific Talar Dome Total Ankle Prostheses (Sloped, Size 2, Right) because the metal coating labels contain incorrect symbols. This labeling error could lead to improper medical use if the implant is not correctly identified.
The implant labels and instructions (IFU) list an incorrect metallic coating material symbol. This could cause confusion during medical procedures if the implant's material is misidentified, potentially affecting the surgical outcome.
Patients who received the recalled Talar Dome Total Ankle Prostheses (Sloped, Size 2, Right) from Integra LifeSciences are most at risk. Healthcare providers who use these implants should also check their records.
Check for the product number LJV182T on the implant label or packaging. The specific model is Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right.
Look for the product number LJV182T on the implant label or packaging.
The recall is due to incorrect metallic coating material symbols on the implant labels and instructions, which could lead to confusion during medical procedures.
Check for the product number LJV182T on the implant label or packaging. The specific model is Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right.
The recall does not require immediate action; check the product label to confirm if it is affected.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1170-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1170-2019 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.
