Events

Retiro De Equipo (Recall) de E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Amplitude 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-2017-RN-00859-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-07-12
  • 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-2017-RN-00859-1
  • 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
    In december 2016, a recall action was undertaken (rc-2016-rn-01625-1) following customer complaints about the e.To.I.L.E extension table regarding abnormal wear in the locking system of the external rotation. at this time, the manufacturer, amplitude were to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.An additional analysis of the e.To.I.L.E extension table has been performed and concludes that a design modification of the locking system is recommended to reduce the risk of lack of locking in external rotation. therefore, amplitude has decided to exchange all the e.T.O.I.L.E systems on the market for systems manufactured according to a new design.
  • Acción
    As a precautionary measure, Amplitude has decided to exchange all the E.T.O.I.L.E systems on the market by systems manufactured according to new design.

Device

E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)
  • Modelo / Serial
    E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)Reference Number: 3-0499902Serial Numbers: 159722, 159724, 167258, 169723 and 169979ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd