Z-0799-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2020
- Initiation Date
- March 14, 2019
- Termination Date
- March 16, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20 units
Product Description
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Code Information
Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617