Events

Recall of Sybron Elements Obturation Unit

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by SybronEndo A Division of Ormco Corp.

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
    14149
  • Event Initiated Date
    2013-01-30
  • 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: Law and Accounting Professional Trustees Limited, 336, Jackson Street, Petone
  • Reason
    The manufacturer advises that a cautionary statement label was inadvertently omitted from the power cord of the elements obturation unit and the replacement power cords shipped between march 2011 and december 2012.
  • Action
    Product to be modified

Device

Sybron Elements Obturation Unit

Manufacturer

SybronEndo A Division of Ormco Corp