Recall Z-2797-2020
Wright Medical Technology, Inc. · initiated July 28, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: product is not lot coded
Reason for recall
Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws.
FDA-determined cause: Device Design
Action taken
Wright disseminated the notices by Fed Ex and email on 07/28/2020. The notices requested the following actions: " Cease using the screw and driver combinations: Dart-Fire 2.5mm Headless Screw with HCS-056-25 1.5 Hex Driver and Dart-Fire 3.0mm Headless Screw and 44112001 2.0 Hex Driver " Disseminate this notice to all those who need to be aware within your organization. " Ensure that you have the right products for removal surgery through pre-operative planning and coordinating with your Wright Medical Representative. The firm will provide a new kit when available.
Details
- Recall number
- Z-2797-2020
- Initiated
- July 28, 2020
- Terminated
- November 16, 2022
- Product code
- LRO – General Surgery Tray
- Quantity
- 9 units
- Distribution
- US Nationwide distribution including in the states of CO, TX, OR, KX, SC, CA, AR, NJ, UT, VA, MO, NC, FL, IL.
- Recalling firm
- Wright Medical Technology, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2796-2020 Class II | Hardware removal kit, Part Number 1985KIT1 - Product Usage: The Wright Medical hardware…Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. | 07/28/2020Terminated |