Events

Recall of Zoo Master Pack 3D 1/4" M/H Fox (elastomeric component for orthodontic applications)

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-00100-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-01-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00100-1
  • 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 are requesting return of the product because complaints have been received that some of the individual bags within the fox zoo master pack were mislabelled as rabbit elastics even though they contained fox elastics.
  • Action
    Ormco are requesting users return all affected stock for replacement with unaffected stock or credit.

Device

Zoo Master Pack 3D 1/4" M/H Fox (elastomeric component for orthodontic applications)
  • Model / Serial
    Zoo Master Pack 3D 1/4" M/H Fox (elastomeric component for orthodontic applications)Part Number: 630-0032Lot Number: 051389150AUST L: 104769
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd