Events

Recall of TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by SMITH & NEPHEW INC..

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
    77177
  • Event Risk Class
    III
  • Event Initiated Date
    2016-07-19
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Smith & nephew inc. has initiated a field correction of various lots of the trigen internal hexrecon screw due to a packaging error. based on internal evaluation various lots of the screws were distributed with an incorrect ifu. the fracture fixation ifu was packaged with the device instead of the correct ifu intramedullary nail system.

Device

TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS
  • Model / Serial
    Model Catalog: 71642365 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    TRIGEN TITANIUM NAIL SYSTEM - INTERNAL HEX RECON SCREWS
  • Manufacturer
    SMITH & NEPHEW INC.

Manufacturer

SMITH & NEPHEW INC.