Device product
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Z-0799-2020
Product summary
- Event
- Event 84350
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 units
- Official record key
device-enforcement:Z-0799-2020
Official wording
Reason: A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
Code information: Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Distribution pattern: US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Derived failure modes
-
Potency or specification failure
out of specification