FDA Medical Device Recalls (openFDA)
Trilliant Surgical, LLC: Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
- Recall number
- Z-0799-2020
- Recalling firm
- Trilliant Surgical, LLC
- Product
- Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
- Status
- Terminated
- Initiated
- 2019-03-14
- Posted
- not on file
- Terminated
- 2022-03-16
- Reason
- 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.
- Root cause
- Process control
- 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.
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
- Lot, serial or model codes
- Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HXX
- Firm FEI
- 3007420745
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28