Events

Recall of LSX Files, 25mm (Powered endodontic rasp)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Ormco 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
    Recall
  • Event ID
    RC-2012-RN-01259-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-12-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01259-1
  • 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
    It has come to ormco's attention that the packages labelled as lsx 25mm files actually contain 30mm lsx files.
  • Action
    Return affected lots to Ormco for replacement with unaffected stock.

Device

LSX Files, 25mm (Powered endodontic rasp)
  • Model / Serial
    LSX Files, 25mm (Powered endodontic rasp)Part Number: 835-4525Lot Number: 091274190ARTG Number: 113801
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd