[Recalled] Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Right, Part No. LJU202T — The Salto Talaris and Integra XT Revision implant labelling was found to list a… | FDA 2019-03-08

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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• C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System — Class II
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• C7000 - CUSA¿ Clarity Ultrasonic Tissue Ablation System — Class II
• Footswitch accessory to the CUSA Clarity Ultrasonic Tissue Ablation System; Catalogue No: C7000 Product Usage: The footswitch is a component of the CUSA Clarity Ultrasonic Surgical Aspirator System, which is indicated for use in surgical procedures where fragmentation, emulsification and aspirat — Class II
• Talar Dome Total Ankle Prosthesis, Flat Cut, Size 3, Right, Product No. LJU813T — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.