Events

Retiro De Equipo (Recall) de Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Device Technologies Australia 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-2014-RN-00154-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-24
  • 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-2014-RN-00154-1
  • 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
    Device technologies australia has become aware that the packaging of the cup removal instruments may not provide a sufficient safety barrier when handling and transporting instruments.
  • Acción
    The distributors are advised to identify and isolate affected product from use, making sure to handle carefully. A Device Technologies Australia Pty Ltd's representative will contact the distributor to organise a time to repackage affected stock at their site. This re-packaging will consist of: ? Adding a new black cap to the blade ? Wrapping the blade head in bubble wrap and securing with tape. ? Re-packaging in the original packaging ? Addition of a warning sticker ? Addition of compliant labelling

Device

Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minim...
  • Modelo / Serial
    Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)Multiple Product Codes
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd