Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product… recallZ-0799-2020 · Trilliant Surgical, LLC · initiated Mar 14, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Trilliant Surgical, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-0799-2020
- Status
- Terminated
- Initiated by the company
- Mar 14, 2019
- Recalling firm
- Trilliant Surgical, LLC
- Quantity
- 20 units
- Product code
- HXX
- Distribution
- US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Product description
Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Code information (models, lots, serial numbers)
Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Gridlock Ankle Screw Driver Bit 320-35-003Trilliant Surgical, LLC · Screwdriver1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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