Recall Z-2797-2020— Wright Medical Technology, Inc.
Class II · Terminated
Class II FDA medical device recall by Wright Medical Technology, Inc., initiated 2020-07-28, terminated 2022-11-16. FDA's recall record names no specific 510(k) clearance for this event. 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: Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws..
- Recalling firm
- Wright Medical Technology, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-28
- Terminated
- 2022-11-16
- Firm location
- Memphis, TN, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.