Events

Recall of Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Smith & Nephew 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-2016-RN-00980-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00980-1
  • 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
    Smith & nephew pty ltd is advising several lots of trigen internal hex captured recon screw blue 6.4mm x 65mm were supplied with incorrect instructions for use (ifu). the fracture fixation ifu (reference 81078017) was packaged with the device instead of the correct intramedullary nail system ifu (reference 81090283). affected products do not need to be returned. the affected products meet all other product specifications and can be used.
  • Action
    Smith & Nephew are providing users with the correct Instructions for Use (IFU). This action has been closed-out on 23/05/2017.

Device

Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as p...
  • Model / Serial
    Trigen Internal Hex Captured Recon Screw Blue 6.4mm x 65mm (Internal fixation screw supplied as part of the Intramedullary Nail System)Model Number: 71642365Batch Numbers: 12BM01456, 12FM15060, 12JM09146, 13AM18101, 13EM08756, 13GM11807, 13GM11808, 13GM18304, 13GM20483, 13GM20486, 13HM20836, 15CM19083, 15FM02129ARTG Number: 104369
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd