Retiro De Equipo (Recall) de Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)

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-2013-RN-00631-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-06-25
  • País del evento
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
  • 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
    Synthes australia has received complaints in relation to breakages experienced with the reduction insert and pieces during spine surgery utilising the reduction instrument for spondylolisthesis, standard, for matrix 5.5.Once the reduction insert breaks, the instrument does not function as required.
  • Acción
    Synthes are requesting their customers to immediately identify and quarantine any affected units. Local sales representatives will assist in the recovery of affected devices.

Device

  • Modelo / Serial
    Reduction Instrument for Spondylolisthesis, standard, for Matrix 5.5(Reusable surgical instrument supplied as part of the fixation system implantation kit)Part Number: 03.632.008 All lot numbers affectedARTG Number: 155807
  • Manufacturer

Manufacturer