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FDAMarch 8, 2019device

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

integra lifesciencesintegra

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T — Recall Details · AllClear