FDA-Device2020-01-22Class II
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Trilliant Surgical, LLC
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.
Sold states
US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Affected count
20 units
Manufactured in
727 N Shepherd Dr Ste 100, Houston, TX, United States
Products
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief