Trilliant Surgical Ltd.

FDA Regulatory Profile

Summary

Total Recalls
23
510(k) Clearances
18
Inspections
6
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1635-2020Class II8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00November 4, 2019
Z-1892-2020Class II3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)0081292602October 10, 2019
Z-0799-2020Class IIGridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant inMarch 14, 2019
Z-1607-2020Class IIInstructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist SJuly 19, 2018
Z-1609-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd GriJuly 19, 2018
Z-1606-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant SurgicalJuly 19, 2018
Z-1605-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant SurgicalJuly 19, 2018
Z-1611-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S July 19, 2018
Z-1613-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd GriJuly 19, 2018
Z-1614-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd SmaJuly 19, 2018
Z-1610-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd TwoJuly 19, 2018
Z-1612-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant SurgicalJuly 19, 2018
Z-1608-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd DisJuly 19, 2018
Z-2339-2018Class IIRatcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non SterileMarch 27, 2018
Z-2338-2018Class IICannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non SterileMarch 27, 2018
Z-0960-2017Class IITiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a componDecember 8, 2016
Z-0609-2017Class IIModel 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x September 2, 2016
Z-2490-2015Class II7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock FAugust 6, 2015
Z-2738-2015Class II2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-SJuly 31, 2015
Z-2456-2015Class IIConcave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer HJuly 20, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K212378Arsenal Ankle Plating SystemFebruary 23, 2022
K191009Arsenal Plating SystemAugust 12, 2019
K181898Two-Step Implant SystemOctober 26, 2018
K172405SNIPER STAPLE SYSTEM, NON-STERILEDecember 11, 2017
K172178Minimally Invasive Bunion Plating SystemNovember 16, 2017
K162354Sniper Staple SystemApril 20, 2017
K160177Gridlock Ankle Plating SystemApril 22, 2016
K153338Tiger Cannulated Screw SystemJanuary 14, 2016
K130964GRIDLOCK PLATING SYSTEMMay 8, 2013
K123525GRIDLOCK PLATING SYSTEMFebruary 15, 2013
K122959HAMMER TOE IMPLANTNovember 7, 2012
K121452GRIDLOCK PLATING SYSTEMAugust 20, 2012
K121008TRILLIANT SURGICAL K-WIRESJune 4, 2012
K111834DISCO SUBTALAR IMPLANTDecember 6, 2011
K112737TIGER HEADLESS CANNULATED SCREWSOctober 20, 2011
K103183TRILLIANT SURGICAL SUBTALAR IMPLANTFebruary 8, 2011
K081510TIGER CANNULATED SCREW SYSTEMAugust 4, 2008
K0729223S HEMI TOENovember 28, 2007