Events

Retiro De Equipo (Recall) de Arthrex ITD Articulating Arm 300 + 350MM

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-2016-RN-01192-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-09-12
  • 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-2016-RN-01192-1
  • 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
    The manufacturer has identified that the rivets of the rotation on the item ‘vesa 75 / 100 adapter connection with rotation’, which is an integral part of the articulating arm 300 + 350mm, may not have been executed in accordance with the relevant standards. the rivets may be weak. in exceptional cases, the connection panel may become loose or detached when subjected to continuous operation. this may potentially endanger the safety of patients, users or third parties. there have been no reported cases of loss or damage in the field related to this issue.
  • Acción
    Device Technologies is advising users that a repair kit will be provided to all affected customers to correct the device. This action has been closed-out on 18/05/2017.

Device

Arthrex ITD Articulating Arm 300 + 350MM
  • Modelo / Serial
    Arthrex ITD Articulating Arm 300 + 350MMProduct Code: AR-5995SAS-FP30Serial Numbers: 001-061736, 001-061740, 001-061742, 001-061745 ARTG Number: 207096
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd