Device product
T25 Cannulated Screwdrivers (CSD 025) packaged in Guide Wire Kits (GWK 300) - Product Usage: Intended to be used to insert screws with T25 driving features, which includes screws with diameters of 5.5mm, 6.5mm, and 7.3mm Product Code: GWK 300
Z-1698-2021
Product summary
- Event
- Event 87906
- Status
- Terminated
- Classification
- Class II
- Quantity
- 47 units
- Official record key
device-enforcement:Z-1698-2021
Official wording
Reason: Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages
Code information: Lot Numbers: 2003320898, 1810220041, 1802220008, 1802220005, 1711220035 UDI: 00840118110853
Distribution pattern: US Nationwide distribution in the states of AZ, CO, FL, GA, IL, IN, PA, NC, VA.
Derived failure modes
-
Unknown
Cannulated Screwdrivers may break at the driver tip along the shaft, near the handle extending surgery time and additional x-ray to identify the fragments from the breakages