Events

Recall of Tornier Humeral broaches Aequalis (6/6.5 diameter)

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

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
    17865
  • Event Initiated Date
    2015-01-12
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • Reason
    Tornier have identified that the humeral broaches aequalis can become more fragile over time resulting in breakage during surgery.
  • Action
    Product to be exchanged

Device

Tornier Humeral broaches Aequalis (6/6.5 diameter)
  • Model / Serial
    Model: Part Numbers: MWA025, MWA026, MWA027, Affected: All lot numbers
  • Manufacturer
    Tornier SA

Manufacturer

Tornier SA