Retiro De Equipo (Recall) de DePuy Synthes Confidence Kit Spinal Cement System

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

¿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
    (jjm) is initiating a recall of depuy synthes confidence kit spinal cement system has received reports where the confidence cement products were difficult to visualize on x-ray, or could not be visualized on x-ray. it was identified that the confidence cement kit lots impacted by this field action may contain confidence cement products with incorrect amounts of contrast medium. the contrast medium allows for visualisation of the cement under x-ray imaging.
  • Acción
    Johnson & Johnson is advising users to inspect stock and quarantine any remaining units of the affected product for return.


  • Modelo / Serial
    DePuy Synthes Confidence Kit Spinal Cement SystemProduct Number: 283910000Confidence Plus Kit Spinal Cement System, 11ccLot Numbers: 133824, 145665, 145664, 135476, 152906Confidence Kit Spinal Cement SystemLot Numbers: 133831, 145669, 152908, 153883, 154956, 154957ARTG Number: 211565
  • Manufacturer