Trilliant Surgical Ltd.: 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

Recall number

Z-2738-2015

Recalling firm

Trilliant Surgical Ltd.

Product

2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE. For use with the Gridlock Plating System for trauma and reconstructive procedures of small bones.

Status

Terminated

Initiated

2015-07-31

Posted

2015-09-04

Terminated

2017-01-26

Reason

Gridlock screw driver bits for the Gridlock Plating System were identified to be out of specification and have the potential for shallow engagement between the driver and the screw, resulting in an increased likelihood of stripping screw heads intraoperatively. Specifically, the minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.

Root cause

Component design/selection

Action

The firm sent out a written notification of the recall on 7/31/2015.

Quantity

108 units

Distribution

NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX

Lot, serial or model codes

TSL002605

510(k) numbers

["K121452"]

PMA numbers

not on file

Product code

HRS

Firm FEI

3007420745

Firm city

Houston

Firm state

TX

Firm country

not on file

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

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