Events

Recall of Tiger Large Cannulated Headless Screw 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
    75187
  • Event Risk Class
    Class 2
  • Event Number
    Z-0609-2017
  • Event Initiated Date
    2016-09-02
  • Event Date Posted
    2016-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149612
  • 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
    Screw, fixation, bone - Product Code HWC
  • Reason
    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.
  • Action
    The firm sent out written notifcation of the recall on 9/2/16; the letter instructed the consignees to discontinue use of the affected lot, quarantine, and return product of the affected lot in accordance with an included acknowledgement sheet.

Device

Tiger Large Cannulated Headless Screw System
  • Model / Serial
    Lot TSL003721
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA, AZ, WI, FL, NJ, OH
  • Product Description
    Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x 110 mm labeled as "7.0 x 110mm LTTHCS REF 208-70-110 QTY 30 LOT TSL003721 2016-03-29 Trilliant Surgical, LTD"
  • Manufacturer
    Trilliant Surgical Ltd.

Manufacturer

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