medical Class II Updated 2019-04-24

Integra LifeSciences Corp. recalls Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left,

Recalled Product

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T


Hazard / Issue

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

Issued by

FDA

Affected States: 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, WI
Lot/Code Info: 180081
View official government recall

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