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Trilliant Surgical, LLC recalls Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Recalled January 22, 2020 · FDA recall Z-0799-2020 · Trilliant Surgical
Hazard
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. · FDA Class II
Units
20 units
Sold at
US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Description
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.
Product
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Manufacturer(s)
Trilliant Surgical, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →