Events

Recall of TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew Surgical Pty 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
    RC-2014-RN-00757-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00757-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has identified a manufacturing error which results in the proximal lag screw being positioned incorrectly. in the event an incorrectly positioned proximal lag screw hole inhibits drilling and causes the user to hit the nail, the following issues could occur: the nail is removed and/or the procedure is delayed, the nail’s fatigue life is reduced, causing the nail to fail within a short period of time.
  • Action
    The affected customer has been requested to inspect their inventory and quarantine the affected stock. The local Smith & Nephew Surgical representative will contact the customer to arrange for the product to be returned.

Device

TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125D
  • Model / Serial
    TRIGEN INTERTAN Intramedullary Nail 13MM X 20CM 125DBatch Number: 14CM03676Model Number: 71675206ARTG Number: 104370
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd