Events

Recall of Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance (M.A.R.A.)

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-00614-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-06-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00614-1
  • 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 has become aware that the rpe screw assembly in palate expander devices is missing a complete weld joining one side of the arm with the screw body. only a single device potentially affected by this issue is in use.
  • Action
    Ormco are asking their customer to inspect the patient's device at their next appointment. If an incomplete weld is identified, the orthodontist is required to either continue to monitor the patient during the time the palate expander treatment or remove the device and return to Ormco for replacement,

Device

Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance...
  • Model / Serial
    Mini RPE Screw Assembly (Orthodontic Appliance System)Mandibular Anterior Repositioning Appliance (M.A.R.A.)Part number: 3000-0012All Devices manufactured from 3 April 2013 to 21 May 2013.ARTG Number: 110055
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd