CLASS II Device recall · Reported 16 Sep 2015 · FDA Enforcement Report

4, 0, and Gridlock Screw Driver Bit recalled by Trilliant Surgical

Trilliant Surgical is recalling 4, 0, and Gridlock Screw Driver Bit, distributed in 19 states. The recall was initiated on 31 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTSL002605

Quantity recalled108 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2738-2015
FDA event ID: 71936
Recalling firm: Trilliant Surgical, Houston, TX
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2015
FDA classified: 4 Sep 2015
Reported: 16 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

31 Jul 2015	Recall initiated by company
4 Sep 2015	Classified by FDA	+35 days
16 Sep 2015	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Arkansas Arizona California Florida Georgia Iowa Illinois Indiana Minnesota Missouri New Jersey New York Ohio Oklahoma South Carolina South Dakota Texas Virginia Wisconsin

Questions about this recall

Is 4, 0, and Gridlock Screw Driver Bit recalled?

Yes. Trilliant Surgical recalled 4, 0, and Gridlock Screw Driver Bit on 31 Jul 2015. The recall is Class II and its status is Terminated. Recall number Z-2738-2015.

Why was it recalled?

Which lots are affected?

TSL002605

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Trilliant Surgical

All 23

Reported	Class	Recall	Company	Reason	Where
13 May 2020Device	CLASS II	Aresenal Screw Drill Bit recalled by Trilliant Surgical	Trilliant Surgical	Labeling Errors	Nationwide
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states
8 Apr 2020Device	CLASS II	Instructions for Use and Surgical Cleaning recalled	Trilliant Surgical	Sterility	29 states

Other Other Medical Devices recalls

All 13,778

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Citric Complete Dry Citric Acid Concentrate recalled	Nipro Renal Soultions USA	Other	Nationwide
16 Sep 2026Device	CLASS I	Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	Halyard IV Start Kit Non-Sterile recalled by Avid Medical	Avid Medical	Sterility	Nationwide
16 Sep 2026Device	CLASS I	Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries	Medical Action Industries Inc. 306	Sterility	6 states
16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide