Food, drugs, devices › Trilliant Surgical Ltd.

Device recall: 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-4

FDA enforcement event 71783 · Class II · initiated 20 Jul 2015 · status Terminated · terminated 26 Jan 2017

DeviceVoluntary: Firm initiated1 product recordHouston, TX

FDA enforcement event 71783 is a device recall by Trilliant Surgical Ltd. of Houston, TX, initiated 20 Jul 2015 and classified Class II, with 1 product record.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 26 Jan 2017. Initiation: voluntary: firm initiated. Trilliant Surgical Ltd. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Trilliant Surgical Ltd., Houston, TX.

Reason for recall

"The cutting efficiency of the Countersinks was out of specification."

Distribution

"US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2421-2015	2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Countersink Part # 210-40-002 NON-STERILE Product Usage: The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis, and osteotomies of the small bones in the hand…	102 units	Class II	Terminated	26 Aug 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Trilliant Surgical Ltd.

Initiated	Product (first record)	Type	Class	Records
27 Mar 2018	Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile	Device	Class II	2
8 Dec 2016	Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a component of a system indic	Device	Class II	1
2 Sep 2016	Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-7	Device	Class II	1
6 Aug 2015	7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part #	Device	Class II	1
31 Jul 2015	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	Device	Class II	1
20 Jul 2015	3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation Syste	Device	Class II	1
20 Jul 2015	Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Re	Device	Class II	1
20 Jul 2015	Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE;	Device	Class II	1

All 9 events for Trilliant Surgical Ltd.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "The cutting efficiency of the Countersinks was out of specification."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "US Nationwide Distribution in the states of: NY, CT, TN, TX, OH, IN, LA, NC, MO, MN, GA, FL, SC, WA, WI, IA, PA, CA, ND, OK, NJ, MI and MD."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 Jan 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.