Events

Recall of Unitek Victory Mini Tube Lower Left Buccal TubePack of 5

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by 3M Australia 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-2015-RN-00937-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2015-09-18
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00937-1
  • 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
    Due to operator error, the labelling for this specific batch is incorrect. the notation on the blister lid shows the contents to be a lower right buccal tube, when the blister actually contains a lower left buccal tube. the catalogue number and batch number are correct and the outer box labelling is correct.There is no risk to the patient. the error is easily recognised by the orthodontist, upon visual inspection prior to use.
  • Action
    The affeted customer is requested to inspect and quarantine stock on hand prior to arranging a return for either replacement or credit. This action has been closed-out on 18/08/2016.

Device

Unitek Victory Mini Tube Lower Left Buccal TubePack of 5
  • Model / Serial
    Unitek Victory Mini Tube Lower Left Buccal TubePack of 5Catalogue number: 3067-8373 Batch number: GQ9SZ-0005ARTG Number: 99491
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

3M Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    3m Company
  • Source
    DHTGA