Events

Recall of SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Emergo Asia Pacific Pty Ltd T/a Emergo Australia.

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-01337-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-12-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01337-1
  • 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
    The manufacturer has initiated a recall due to a product mislabelling which may result in inefficient treatment of the patient and could require further medical intervention to replace the wire.- product labelled as “upper” may contain “lower” archwires with a red midline mark- product labelled as “lower” may contain “upper” archwires with a black midline mark.
  • Action
    Emergo is advising users to return affected devices for replacement.

Device

SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order t...
  • Model / Serial
    SuperElastic NiTi Archwires (intended to provide force to the teeth to effect movement in order to alter their position)SE Niti 014 Nat U 100Part Number: 11100141124Lot Number: 41756SE Niti 014 Nat L 100Part Number: 11100141144Lot Number: 41760ARTG Number: 165070
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia