FDA recall Z-0799-2020

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-03-14

Report date

2020-01-22

Termination date

2022-03-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Houston, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2020