Events

Retiro De Equipo (Recall) de Inserter f/TEN

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
    Recall
  • ID del evento
    RC-2015-RN-00185-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-11
  • 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-2015-RN-00185-1
  • 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 affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during use. it is important to note that the removal of the ten inserter would prevent the performance of emergency surgery, thus synthes gmbh is not requiring an immediate return of affected product(s).
  • Acción
    JJM is providing work around instructions to prevent the breaking of the cross/transversal bar and jamming of the chuck. The manufacturer, Synthes GmbH, is in the process of developing the replacement & recovery plan for indicated devices and will contact their customers as replacements become available. This action has been closed-out on 06/06/2016.

Device

Inserter f/TEN

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes