Events

Recall of Generation 1 Jasper Vektor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by TP (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-2018-RN-00482-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2018-05-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00482-1
  • 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
    Tp orthodontics has been made aware of incidents of device breakage as a result of stress overload. to date, no reports of serious injury have been received as a result of this issue.
  • Action
    TP Australia is requesting customers: 1. Locate any of the affected lots identified in the table given in the customer letter and quarantine those products; and 2. Return the Generation 1 Jasper Vektor for a replacement Jasper Vektor Generation 2 or for a suitable refund, following the instructions given in the Customer Letter.

Device

Generation 1 Jasper Vektor
  • Model / Serial
    Generation 1 Jasper VektorMultiple Catalogue and Lot NumbersARTG Number: 123576TP (Australia) - Orthodontic appliance, attachment
  • Manufacturer
    TP (Australia) Pty Ltd

Manufacturer

TP (Australia) Pty Ltd