Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-2796-2020

July 28, 2020

Class II

Product summary

Firm
Wright Medical Technology, Inc.
Event
Event 85982
Status
Terminated
Classification
Class II
Quantity
66 kits
Official record key
device-enforcement:Z-2796-2020

Official wording

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

Code information: Lot Codes: 01 through 64, 66 and 67

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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