Z-0799-2020Class II

Gridlock Ankle Screw Driver Bit REF 320-35-003 -

Name: Z-0799-2020 Gridlock Ankle Screw Driver Bit REF 320-35-003 -
Creator: Trilliant Surgical, LLC
Published: 2019-03-14
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2019-03-14 / Terminated / root cause: manufacturing process

FDA source

Trilliant Surgical, LLC began a recall of Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal on 2019-03-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0799-2020
Classification: Class II
Status: Terminated
Initiated: 2019-03-14
Posted: 2020-01-10
Terminated: 2022-03-16
Recalling firm: Trilliant Surgical LLC
Product: Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Product code: HXX Screwdriver
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 20 units
Distribution: US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
Product codes and lots: Part Number: 320-35-003 Lot Number: TSL006617 UDI: (01)00812926026893(10)TSL006617

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0799-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0799-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)