FDA recall Z-2797-2020

Wright Medical Technology, Inc. · Class II · device

Product

Screw Removal Case Assembly, Part Number 1985BASE - 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.

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2020-07-28
Report date
2020-08-19
Termination date
2022-11-16
Voluntary/Mandated
Voluntary: Firm initiated
Location
Memphis, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2797-2020