Events

Retiro De Equipo (Recall) de Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)

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-00371-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-27
  • 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-00371-1
  • 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 wrong material (stainless steel) is indicated on the product label. the product is made of cobalt chrome. there is a potential harm associated with the mislabelled product for adverse tissue reaction especially if the guidewire breaks during surgery and a fragment is retained.
  • Acción
    Synthes is notifying their customers of the incorrect information on the product labels and is providing additional safety advice to mitigate the risk of cobalt sensitivity reactions.

Device

Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)
  • Modelo / Serial
    Guide Wire Ø 3.2 mm, length 400 mm (used for the implantation of intramedullary nails)Part number: 357.399Lot Numbers: All lot numbers prior to 7527384 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd