Events

Recall of Zoo Pack Elastics Master Pack 2E 3/16 Hvy Kangaroo (Orthodontic elastic bands)

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-01035-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2012-10-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01035-1
  • 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 is recalling this product because boxes of zoo pack elastics labelled to contain packages of kangaroo elastics may contain packages of kangaroo and impala elastics. although an inconvenience, there are no safety or efficacy issues involved with this product.
  • Action
    Return the product to the sponsor for replacement.

Device

Zoo Pack Elastics Master Pack 2E 3/16 Hvy Kangaroo (Orthodontic elastic bands)
  • Model / Serial
    Zoo Pack Elastics Master Pack 2E 3/16 Hvy Kangaroo (Orthodontic elastic bands)Part Number: 630-0040Lot Number: 061277866ARTG Number: 104769
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd