Recall of 7, 9, and 11Hole VL Gridlock Fibula Plating System

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
    71967
  • Event Risk Class
    Class 2
  • Event Number
    Z-2490-2015
  • Event Initiated Date
    2015-08-06
  • Event Date Posted
    2015-08-31
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2017-01-26
  • Event Source
    USFDA
  • Event Source URL
  • 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
    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 locking screws.
  • Action
    Trilliant Surgical sent an Urgent Medical Device Recall letter dated August 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed and confirmed consignees to discontinue use of the affected lots, quarantine, and return product (if not yet done so) in accordance with an included acknowledgement sheet. For further questions, please call 1(800) 495-2919 , 8:00am - 5:00pm CST

Device

  • Model / Serial
    Lots: TSL002595, TSL002596, TSL002597
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : FL, OH, NJ, MN, WI, NM and CA.
  • Product Description
    7 Hole VL Gridlock Fibula Plate, Part # 300-60-001 NON-STERILE SINGLE USE ONLY; 9 Hole VL Gridlock Fibula Plate, Part # 300-60-002 NON-STERILE SINGLE USE ONLY; 11 Hole VL Gridlock Fibula Plate, Part # 300-60-003 NON-STERILE SINGLE USE ONLY. For use in trauma and reconstructive procedures in small bones.
  • Manufacturer

Manufacturer

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