Hardware removal kit recalled over fire hazard

Recall date

July 28, 2020

Source

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

Official notice title

Wright Medical Technology, Inc. recalls Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to faci…

Recall number

Z-2796-2020

FDA classification

Class II

Brand / firm

Wright Medical Technology, Inc.

Sold / distributed

US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.

Why it was recalled

Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.

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

What was recalled

Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware removal kit is designed to facilitate removal of both plates and screws used in foot and ankle procedures. Along with a complete range of drivers, the kit also features driver handles and a range of k-wires to assist in removal of cannulated screws. This product is a multiple use, non-sterile instrument.