RegWardenFDA facility compliance records
Facility

Trilliant Surgical LLC

13 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2015: 6 recalls; 2016: 2 recalls, 1 inspections; 2018: 2 recalls, 1 inspections; 2019: 3 recalls, 1 inspections6201532016201732018420192020202120222023202420252026
  • Recalls (13)
  • Inspections (3)

Devices registered here (1)

Recalls & enforcement

20193 records
  • Class IITerminated2019-11-04
    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 kit…
  • Class IITerminated2019-10-10
    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.
  • Class IITerminated2019-03-14
    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.
20182 records
  • Class IITerminated2018-07-19
    Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
  • Class IITerminated2018-03-27
    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.
20162 records
  • Class IITerminated2016-12-08
    Four lots of Tiger Screw Sterilization Tray Base Assemblies were released to the field with a printing error where k-wire description markings indicate diameters of 0.45 and 0.35 instead of 0.045" and 0.035", respectively.
  • Class IITerminated2016-09-02
    Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number incorrectly indicated lot number of TSL003765 rather than TSL003721.
20156 records
  • Class IITerminated2015-08-06
    The affected parts subject to the recall are out of specification, resulting in in the loss of the optimal locking screw functionality of the plates. The thread depth of the screw holes is insufficient, potentially limiting the ability to engage and lock with associated mating l…
  • Class IITerminated2015-07-31
    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…
  • Class IITerminated2015-07-20
    The cutting efficiency of the Countersinks was out of specification.
  • Class IITerminated2015-07-20
    Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray.
  • Class IITerminated2015-07-20
    The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
  • Class IITerminated2015-07-20
    The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through.

FDA inspections (3)

  • VAI2019-12-11
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • VAI2018-05-02
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
  • NAI2016-06-27
    No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Trilliant Surgical LLC (FEI 3007420745) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007420745-trilliant-surgical-llc/

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