Events

Retiro De Equipo (Recall) de T-Adaptation Plate 1.3, head 3 holes, shaft 8 holes, Stainless Steel, and T-Adaptation Plate 1.3, head 4 holes, shaft 8 holes, Stainless Steel (orthopaedic fixation plates)

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-00123-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-05
  • 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-00123-1
  • 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 listed lot numbers of the t-adaptation plate 1.3, 4 holes (221.334) and the t-adaptation plate 1.3, head 3 holes (221.333) were mis-packaged. part number 221.334 was labelled as a 3 hole plate (221.333) instead of a 4 hole plate, whereas part number 221.333 was labelled as a 4 hole plate (221.334) instead of a 3 hole plate.
  • Acción
    Synthes is requesting users inspect and return any affected stock to Synthes for replacement

Device

T-Adaptation Plate 1.3, head 3 holes, shaft 8 holes, Stainless Steel, and T-Adaptation Plate 1.3,...
  • Modelo / Serial
    T-Adaptation Plate 1.3, head 3 holes, shaft 8 holes, Stainless Steel, and T-Adaptation Plate 1.3, head 4 holes, shaft 8 holes, Stainless Steel (orthopaedic fixation plates)Part Numbers: 221.333 and 221.334Lot Numbers: 3488161 and 3488162ARTG Number: 157069
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd