Events

Retiro De Equipo (Recall) de Straight Adjustable Gastric Band Product Code: 2200X & BD2XV

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-01030-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-10-21
  • 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-01030-1
  • 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 ethicon endo-surgery, has determined that the straight adjustable gastric band was unable to pass the internal test for 'force to close'. as a result surgeons may experience difficulty in locking the straight gastric band buckle during implantation. once the product is locked, the gastric band will remain in place and will function as intended.
  • Acción
    JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future.

Device

Straight Adjustable Gastric Band Product Code: 2200X & BD2XV
  • Modelo / Serial
    Straight Adjustable Gastric Band Product Code: 2200X & BD2XVAll lot numbers affectedARTG Number: 94766
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd