Events

Recall of DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Implant Direct Oceania 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-01091-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-10
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01091-1
  • 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
    There is a possible safety issue with the retention of the drill when the dgde is in use. this discrepancy may lead to the possibility of the dgde dropping the drill. the sponsor's current data indicates that the possibility of this occurring is unlikely (less than 0.69%). in the unlikely event that the dgde drops the drill; there is a risk if the product is in use that the drill can possibly fall onto the patient, or into the patient’s oral cavity. the drill could be ingested or aspirated by the patient and this may lead to surgical intervention.
  • Action
    Customers to return the affected products. Sponsor to replace the affected products. This action has been closed-out on 26/08/2016.

Device

DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender
  • Model / Serial
    DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill ExtenderAffected Part Numbers: DGDE, CST, RBST, RCST, SPCST, BST, ICST, IBST.Affected Lot Numbers: 61928, 67055, 67345, 64895, 65405, 67474, 67479, 65410, 67474, 65409, 64898, 65357, 64898, 65357, 64898, 65406, 67474, 68254 and 68265, 65408, 64896.ARTG Number: 245673
  • Manufacturer
    Implant Direct Oceania Pty Ltd

Manufacturer

Implant Direct Oceania Pty Ltd
  • Source
    DHTGA