Events

Recall of Device Recall Gridlock Screw Driver Bit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Trilliant Surgical Ltd..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71936
  • Event Risk Class
    Class 2
  • Event Number
    Z-2738-2015
  • Event Initiated Date
    2015-07-31
  • Event Date Posted
    2015-09-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139413
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Plate, fixation, bone - Product Code HRS
  • Reason
    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 minor diameter of the drive feature is above the specification, potentially reducing the engagement between the driver and the screw head.
  • Action
    The firm sent out a written notification of the recall on 7/31/2015.

Device

Device Recall Gridlock Screw Driver Bit
  • Model / Serial
    TSL002605
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    NY, OH, CA, SC, NJ, AZ, VA, IN, FL, MN, OK, AR, MO, WI, GA, SD, IA, IL, TX
  • Product Description
    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 the Gridlock Plating System for trauma and reconstructive procedures of small bones.
  • Manufacturer
    Trilliant Surgical Ltd.

Manufacturer

Trilliant Surgical Ltd.
  • Manufacturer Address
    Trilliant Surgical Ltd., 6721 Portwest Dr Ste 160, Houston TX 77024-8019
  • Source
    USFDA