Events

Retiro De Equipo (Recall) de Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affected

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.

¿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-00068-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-01-22
  • 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-2013-RN-00068-1
  • 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 cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being 'jammed' or 'stuck' and not able to turn, which could result in surgical delay in order to prepare another kit, or the inability to complete the procedure if an additional kit is not available; thereby exposing the patient to additional anaesthesia in another surgical procedure.
  • Acción
    Customers are being advised to quarantine any affected products and return the products for a credit.

Device

Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers...
  • Modelo / Serial
    Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affectedProduct Codes: 283910000 and 283913000
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd