Recall of Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Synthes Australia 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
  • Event ID
  • Event Risk Class
    Class II
  • Event Initiated Date
  • Event Country
  • Event Source
  • Event Source URL
  • 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
    Labelling changes have been made to synthes external fixation systems (small, medium, large and do) related to mr conditions as a result of changes in the required testing protocols to designate a product mr safe, mr conditional, or mr unsafe.
  • Action
    Synthes is notifying hospitals of the change from 'MR Safe' to 'MR Conditional' for all products affected by this product correction.


  • Model / Serial
    Synthes Trauma External Fixation System (Small, Medium, Distraction Osteogenesis (DO) Ring and Large) Multiple part numbers and lot numbers affectedARTG Numbers: 133919, 133921, 133927, 153950, 155806, 155807, 157068, 183900 & 203638
  • Manufacturer