Z-2738-2015Class II

2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE...

Name: Z-2738-2015 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-STERILE...
Creator: Trilliant Surgical Ltd.
Published: 2015-07-31
License: https://open.fda.gov/license/

Trilliant Surgical LLC / initiated 2015-07-31 / Terminated / root cause: design

FDA source

Trilliant Surgical Ltd. began a recall of 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... on 2015-07-31. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2738-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Posted: 2015-09-04
Terminated: 2017-01-26
Recalling firm: Trilliant Surgical LLC
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: 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 tag: design
FDA root cause: Component design/selection
Action: The firm sent out a written notification of the recall on 7/31/2015.
Quantity in commerce: 108 units
Distribution: NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
Product codes and lots: TSL002605

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2738-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2738-2015	Class II	Terminated	Voluntary: Firm initiated	2015-09-16	2015-09-04

Product code HRS

K121452Class IIGridlock Plating SystemTrilliant Surgical, Ltd. / cleared 2012-08-20

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)