Events

Retiro De Equipo (Recall) de True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and tissue)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Allegra Orthopaedics Limited.

¿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-2015-RN-00926-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-09-17
  • 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-2015-RN-00926-1
  • 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 performed an investigation and determined that the affected lots were not manufactured according to specification in relation to a particular dimension. this created a loose fitting of the blade when it was connected to the power equipment hand piece, resulting in the ineffective oscillation of the blade.
  • Acción
    Allegra Orthopaedics is requesting users to inspect their stocks and quarantine all affected units. Allegra will replace affected stock with a blade of similar size and specification as an interim measure. This action has been closed-out on 04/03/2016.

Device

True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and...
  • Modelo / Serial
    True Cut Oscillating Blade, 0.9mm x 80mm x 12mm, single use device (used to cut skeletal bone and tissue)Lot Numbers: 15040200 and 15039800ARTG Number: 134917
  • Manufacturer
    Allegra Orthopaedics Limited

Manufacturer

Allegra Orthopaedics Limited