Events

Recall of Device Recall Tiger Cannulated 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
    76029
  • Event Risk Class
    Class 2
  • Event Number
    Z-0960-2017
  • Event Initiated Date
    2016-12-08
  • Event Date Posted
    2017-01-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-05-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151974
  • 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
    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.
  • Action
    Trilliant Surgical Ltd. sent an Urgent Medical Device Recall letter dated December 8, 2016, to all affected consignees. The letter instructed the consignees to 1) identify any/all affected product; 2) document any/all identified product via a provided response form and return to Trilliant Surgical; 3) exchange product upon receipt of replacements; and 4) return any/all affected product as originally identified and reported on the return response form. Customers with questions were instructed to call 800-495-2919.

Device

Device Recall Tiger Cannulated Screw System
  • Model / Serial
    Lot: TSL003191, TSL003637, TSL004101, TSL004395
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    Tiger Screw Sterilization Tray Base Assembly Model 210-00-001 Revision N, O || The product is a component of a system indicated for the fixation of fractures, non-unions, arthrodeses, and osteotomies of bones appropriate for the size of the device.
  • Manufacturer
    Trilliant Surgical Ltd.

Manufacturer

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