Recall Z-2797-2020 ยท LRO General Surgery Tray
Wright Medical Technology, Inc.
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.
| Date | Jul 28, 2020 |
| Status | Terminated |
| Reason | Hardware removal kit does not include drivers to remove Dart-Fire 2.5 and 3.0mm Headless screws. |
| Root cause | Device Design |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.