Events

Recall of Synthes Trauma External Fixation System "MR Conditional"

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Synthes GmbH.

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
    16597
  • Event Initiated Date
    2014-05-06
  • 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: Synthes New Zealand Ltd, 507 Mt Wellington Highway, Mt Wellington, Auckland 1060
  • 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 required testing protocols to designate a product mr safe, mr conditional, or mr unsafe. metal devices are no longer identified as mr safe and as a result synthes ex-fix systems are no longer labelled mr safe and should be treated as mr conditional.
  • Action
    Instructions for use to be updated

Device

Synthes Trauma External Fixation System "MR Conditional"
  • Model / Serial
    Model: Various, Affected: Various
  • Manufacturer
    Synthes GmbH

Manufacturer

Synthes GmbH