Recall of JET-X MINI DISTAL RADIUS TIN COATED STAINLESS STEEL HALF PIN 3MM

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
    103575
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-24
  • Event Country
  • 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
    The half pins were produced without the tin (titanium nitride) coating. there is an obvious difference in the colour of the tin coated pins and the non-coated pins as gold versus steel respectively. the pins are also sold as non-sterile where the user would have to remove the pins from the packaging and place them into hospital sterilization trays.

Device

  • Model / Serial
    Model Catalog: 71063202 (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: 71063152 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    Jet-X Mini Distal Radius Half Pin
  • Manufacturer

Manufacturer