Events

Recall of Elements Motor and TF Adaptive Starter Kit (Dental motor used with endodontic rotary instruments)

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-2013-RN-00574-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-06-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00574-1
  • 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
    Ormco is advising that the descriptor field of the file settings may become partially fragmented while in standby mode. this does not change the performance of the device and the rpm/speed or ratio displays remain as depicted in the instructions for use (ifu).
  • Action
    Ormco are providing work around instructions, and will be providing a software update to permanently correct the issue.

Device

Elements Motor and TF Adaptive Starter Kit (Dental motor used with endodontic rotary instruments)
  • Model / Serial
    Elements Motor and TF Adaptive Starter Kit (Dental motor used with endodontic rotary instruments)Elements MotorPart numbers: 815-1500 and 815-1502TF Adaptive Starter KitPart numbers: 815-1530, 815-1531 and 815-1532ARTG number: 193033
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd