Events

Recall of APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)

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-2014-RN-01135-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2014-10-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01135-1
  • 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
    Product content did not match label. a total of 20 boxes (each box contains 5 brackets) of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"" with lot # ft1dg were supplied to 3 orthodontists (end user) in australia in the period 28 july 2014 - 7 august 2014. outer pack label packaging and individual blisters were labelled correctly. the type of bracket supplied within the blister was not correct. the incorrect bracket was ""apc plus victory series twin upper left/right 1st bicuspid with no hook"" instead of ""apc plus victory series twin upper left cuspid -3t/10a with distal hook, slot size 022"".
  • Action
    This action was undertaken prior to approval of the recall strategy by the TGA. Orthodontists supplied with the affected lot were notified. Orthodontists returned affected lots and 19 of the 20 boxes were received. 1 box was not returned. The retrieval rate was 95 %. All products returned were in the original packaging (unopened).

Device

APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal...
  • Model / Serial
    APC Plus Victory Series Twin Upper Left Cuspid -3T/10A with Distal Hook (Unitek Orthodontic Metal Brackets - Orthodontic bracket, metal)ARTG Number: 219341
  • Manufacturer
    3M Australia Pty Ltd

Manufacturer

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