Events

Retiro De Equipo (Recall) de DGDE DirectGuideTM Drill Extender and kits containing the DGDE Drill Extender

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Implant Direct Oceania Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01091-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01091-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Modelo / 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