Events

Rappel de DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Implant Direct Oceania Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-01091-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-10
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01091-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
    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