Trilliant Surgical, LLC recalls Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.

Recall date

March 14, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0799-2020

FDA classification

Class II

Brand / firm

Trilliant Surgical, LLC

Sold / distributed

US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.