Home / Recalls / Medical Devices
Integra LifeSciences Corp. recalls Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
Recalled April 24, 2019 · FDA recall Z-1161-2019 · Integra LifeSciences
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 · FDA Class II
Units
2029
Sold at
Distributors in AL, CA, CT, FL, GA, HI, IA, ID, KS, KY, MD, MI, MO, MT, NC, NE, NJ, NM, NY, OH, OK,PA, TX, VA, WA, and WI.
Description
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
Product
Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →