FDA-Device2020-08-19Class II

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.

Wright Medical Technology, Inc.
Hazard

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

Sold states
US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
Affected count
9 units
Manufactured in
1023 Cherry Rd, N/A, Memphis, TN, United States
Products
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.

Official notice

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

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