Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
FDA Recall Z-0799-2020 · Posted None
Recalling FirmTrilliant Surgical, LLC
Recall StatusTerminated
Product CodeHXX
Date Initiated2019-03-14
Date Terminated2022-03-16
Product Quantity20 units
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.
Firm Action
The recall strategy included sending written recall communication and response forms as of 03/14/2019 via FedEx (Express Standard Overnight)
to all consignees that showed possession / had been sold a device (as the
device is considered reusable) as of 03/14/2019. The communication
instructed the consignees to:
" Check inventory stock for identified devices
" Locate and remove and/or discontinue use of identified devices
" Return all related product(s) to Recalling Firm in accordance with the included return response / acknowledgement form.
Root Cause
Process control
Distribution Pattern
US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.