Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
This recall has been terminated (originally issued March 14, 2019).
- Company
- Trilliant Surgical, Llc
- Recall Initiated
- March 14, 2019
- Terminated
- March 16, 2022
- Recall Number
- Z-0799-2020
- Quantity
- 20 units
- Firm Location
- Houston, TX
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Root Cause
Process control
Action Taken
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.