Events

Recall of Trigen Internal Hex Captured Recon screws Blue 6.4 mm x 65mm

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand 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
    20429
  • Event Initiated Date
    2016-07-28
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Smith & Nephew Surgical Ltd, Unit A 36 Hillside road, Wairau Valley, AUCKLAND 0760
  • Reason
    Several lots of trigen® internal hex captured recon screw blue 6.4mm x 65mm, model # 71642365 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.
  • Action
    Manufacturer to issue advice regarding use

Device

Trigen Internal Hex Captured Recon screws Blue 6.4 mm x 65mm
  • Model / Serial
    Model: Intramedullary Nail System IFU, Affected: 71642365
  • Manufacturer
    Smith & Nephew Inc

Manufacturer

Smith & Nephew Inc