Retiro De Equipo (Recall) de Aequalis IM Nail Targeting Jig(Prosthetic joint 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 Tornier 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • 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
    The targeting jig mast is separating from the jig boom. any separation will impact alignment and can affect the ability to fixate the screws.There has been no impact to a patient to-date; however, a design change to the product is necessary.
  • Acción
    Tornier is developing a design change for the jig. Once the design change has been completed Tornier will arrange for the collection and replacement of the faulty devices. In the interim, Tornier has provided inspection instructions to ensure that faulty devices are not used in surgery.


  • Modelo / Serial
    Aequalis IM Nail Targeting Jig(Prosthetic joint implantation kit)Lots: All lots - (DB0114069, DB0114349, CA46096, CA216052, DB0111264001, DB0112016, DB0113102)Catalogue Number: 9020060ARTG number: 177214
  • Manufacturer