Trilliant Surgical Ltd.
FDA Regulatory Profile
Trilliant Surgical Ltd. appears in FDA public data with 23 recalls, 18 510(k) clearances, 6 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-1635-2020, Class II) was initiated on November 4, 2019. Its most recent 510(k) clearance was granted on February 23, 2022.
Summary
- Total Recalls
- 23
- 510(k) Clearances
- 18
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1635-2020 | Class II | 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00 | November 4, 2019 |
| Z-1892-2020 | Class II | 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)0081292602 | October 10, 2019 |
| Z-0799-2020 | Class II | Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant in | March 14, 2019 |
| Z-1607-2020 | Class II | Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist S | July 19, 2018 |
| Z-1609-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gri | July 19, 2018 |
| Z-1606-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical | July 19, 2018 |
| Z-1605-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical | July 19, 2018 |
| Z-1611-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd 3S | July 19, 2018 |
| Z-1613-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gri | July 19, 2018 |
| Z-1614-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Sma | July 19, 2018 |
| Z-1612-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical | July 19, 2018 |
| Z-1610-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two | July 19, 2018 |
| Z-1608-2020 | Class II | Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Dis | July 19, 2018 |
| Z-2338-2018 | Class II | Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile | March 27, 2018 |
| Z-2339-2018 | Class II | Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile | March 27, 2018 |
| Z-0960-2017 | Class II | Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O The product is a compon | December 8, 2016 |
| Z-0609-2017 | Class II | Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x | September 2, 2016 |
| Z-2490-2015 | Class II | 7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock F | August 6, 2015 |
| Z-2738-2015 | Class II | 2.4, 3.0, and 4.0 mm Gridlock Screw Driver Bit, Model Number 310-30-003, Lot Number TSL002605, NON-S | July 31, 2015 |
| Z-2421-2015 | Class II | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.0 Cannulated Screw Coun | July 20, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K212378 | Arsenal Ankle Plating System | February 23, 2022 |
| K191009 | Arsenal Plating System | August 12, 2019 |
| K181898 | Two-Step Implant System | October 26, 2018 |
| K172405 | SNIPER STAPLE SYSTEM, NON-STERILE | December 11, 2017 |
| K172178 | Minimally Invasive Bunion Plating System | November 16, 2017 |
| K162354 | Sniper Staple System | April 20, 2017 |
| K160177 | Gridlock Ankle Plating System | April 22, 2016 |
| K153338 | Tiger Cannulated Screw System | January 14, 2016 |
| K130964 | GRIDLOCK PLATING SYSTEM | May 8, 2013 |
| K123525 | GRIDLOCK PLATING SYSTEM | February 15, 2013 |
| K122959 | HAMMER TOE IMPLANT | November 7, 2012 |
| K121452 | GRIDLOCK PLATING SYSTEM | August 20, 2012 |
| K121008 | TRILLIANT SURGICAL K-WIRES | June 4, 2012 |
| K111834 | DISCO SUBTALAR IMPLANT | December 6, 2011 |
| K112737 | TIGER HEADLESS CANNULATED SCREWS | October 20, 2011 |
| K103183 | TRILLIANT SURGICAL SUBTALAR IMPLANT | February 8, 2011 |
| K081510 | TIGER CANNULATED SCREW SYSTEM | August 4, 2008 |
| K072922 | 3S HEMI TOE | November 28, 2007 |