Houston, TX, United States
Trilliant Surgical, LLC recalls
5 recalls recorded since 2018, most recently on 4 November 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls5
Ongoing (FDA)0
Terminated or completed5
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 4 November 2019
- Terminated
- 28 April 2021
- Reason
- The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.
- Distribution
- Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1635-2020
- 8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)231225 (10)TSL007202
Terminated Class II Medical devices
- Recall started
- 10 October 2019
- Terminated
- 27 April 2022
- Reason
- Labeling Error; specifically, drill bits from lots # TSL008495A are marked with the lot # of TSL008495. This could lead to parts being misidentified and impact device traceability.
- Distribution
- US Nationwide distribution in the state of CA. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1892-2020
- 3.5mm Aresenal Screw Drill Bit , Ref: 330-35-001, Qty. 70, Rx Only, Non-Sterile, UDI: (01)00812926029696 - Product Usage: A drill bit facilitates implant insertion
Terminated Class II Medical devices
- Recall started
- 14 March 2019
- Terminated
- 16 March 2022
- Reason
- A screwdriver used to facilitate implant insertion and removal was found to be out of specification for the minor diameter of the drive feature causing the driver to be unable to retain screws as intended.
- Distribution
- US Nationwide distribution in the states of CO, CT, IA, TX and WI. OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0799-2020
- Gridlock Ankle Screw Driver Bit REF 320-35-003 - Product Usage: A screwdriver facilitates implant insertion and removal.
Terminated Class II Medical devices
- Recall started
- 19 July 2018
- Reason
- Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
- Distribution
- Distribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1605-2020, Z-1609-2020, Z-1608-2020, Z-1607-2020, Z-1612-2020, Z-1614-2020, Z-1606-2020, Z-1610-2020, Z-1611-2020, Z-1613-2020
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Tiger Cannulated Screw System, Model 210-00-001; and (2) Combination Tiger/Tiger Headless Cannulated Screw System, Mo
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Gridlock Plating System, Model 310-01-100. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Disco Subtalar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
- Instructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Large Cannulated Screw System, Model 215-00-001; and (2) Trilliant Surgical Ltd Large Cannulated Headless
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Small Joint Reaming System, Model 311-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant Surgical Ltd Tiger Headless Cannulated Screw System, Model 212-00-001; and (2) Combination Tiger Cannulated/Tiger Headless Ca
- Instructions for Use and Surgical Cleaning and Sterilization Protocol for Trilliant Surgical Ltd Two-Step Hammertoe Implant System, Model 214-00-001. The firm name on the label is Trilliant Surgical Ltd, Houston, TX.
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 27 March 2018
- Terminated
- 4 June 2020
- Reason
- Firm is voluntarily recalling cannulated driver handles (210-00-003 and 210-00-004) that may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft.
- Distribution
- U.S. States: NE, MA, GA, TX, OR, AZ, FL, OH, WA, NJ, UT, VA, CA, MN, PA, DE, OK, KS, WI, MT, IA, MO
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2339-2018, Z-2338-2018
- Ratcheting Cannulated Driver Handle, Catalog #: 210-00-004, Rx Only, Non Sterile
- Cannulated Driver Handle, Catalog #: 210-00-003, Rx Only, Non Sterile
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.