Integra LifeSciences Corp. recalls Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T

Recall date

March 8, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1165-2019

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

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.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T