Events

Retiro De Equipo (Recall) de Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes 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-00611-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-06-06
  • 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-00611-1
  • 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 packaging for the selected part and lot numbers of the guide wire ø 3.2 mm, length 400 mm were mislabelled with an incorrect material. the label incorrectly declares 'molybdenum' instead of wolfram and nickel as alloyed elements. the correct label should indicate “cocrwni alloy”. during the normal course of the surgery, the risk of adverse tissue reaction is decreased as the guide wire is not retained in the body after the procedure is completed. in the case of a broken guide wire, a fragment may be retained after surgery. in this case, a patient with sensitivity to nickel could develop a moderate adverse tissue reaction.
  • Acción
    Customers are advised to immediately isolate the affected stock for returning to Synthes Australia.

Device

Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)
  • Modelo / Serial
    Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)Part Number: 357.399Lot Numbers: 7560756, 7584396, 7594896, 7560829, 7562800, 7589236, 7594058, 7583667, 7589696 and 7594057 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd