Events

Recall of AEZ Mini Distal Cutter w/ Hold Short (Used to cut archwires during orthodontic treatment)

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-00843-3
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00843-3
  • 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
    Packages labelled as short-handled cutters (part number 803-0500) actually contained long handle cutters (part number 803-0501).
  • Action
    Ormco is asking customers to return the affected lots for replacement or credit.

Device

AEZ Mini Distal Cutter w/ Hold Short (Used to cut archwires during orthodontic treatment)
  • Model / Serial
    AEZ Mini Distal Cutter w/ Hold Short (Used to cut archwires during orthodontic treatment)Part Number: 803/0500Lot Number: 11M35MARTG Number: 104770
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd