Events

Recall of Damon TMA - Low Friction Archwire (orthodontic wire)

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-2014-RN-00697-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-06-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00697-1
  • 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 corporation received a complaint that the product labelling descriptor on the package for damon tma low friction archwires references dimensions that are different from those of the actual wire. the label states that the wire dimension is .017x.020, however the actual dimension is .017x.025. although the product description on the label is incorrect, the part number, lot number, product packaging and the product within the package are correct.
  • Action
    Ormco is advising their customers to be aware of the incorrect information on the package labels.

Device

Damon TMA - Low Friction Archwire (orthodontic wire)
  • Model / Serial
    Damon TMA - Low Friction Archwire (orthodontic wire)Part Number: 227-1112Lot Number: 031430923ARTG Number: 104765
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd