Events

Recall of 8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)

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-2013-RN-00775-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-08-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00775-1
  • 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 have found that some screws in the affected lot were machined undersized at the top of the threads may potentially cause a weakening of the screw. use of the undersized product may result in breakage of the screw during insertion or removal when torqued, possibly requiring surgical removal of any remaining pieces.
  • Action
    Customers are asked to return any of the affected stock remaining in the inventory. Ormco is advising users to continue with normal treatment if the 8 mm screw is believed to have already been placed or in treatment. When the screw is ready to be removed, physicians are requested to take special care and to not over-torque the screw on removal. For more details, please see http://www.tga.gov.au/safety/alerts-device-8mmvectorscrew-130809.htm .

Device

8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)
  • Model / Serial
    8mm Vector TAS Screw and Vector TAS Starter Kit (Orthodontic anchoring screw)8mm Vector TAS ScrewPart Number: 601-0021Lot Number: 112911Vector TAS Start Kit (10 patient)Part Number: 601-0010Lot Number: 112911 (8mm screws from within the kit)ARTG Number: 145039
  • Manufacturer
    Ormco Pty Ltd

Manufacturer

Ormco Pty Ltd