Events

Retiro De Equipo (Recall) de Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)

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-2016-RN-00806-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-15
  • 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-2016-RN-00806-1
  • 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 fastener on the mandible distractor may become prematurely separated from the proximal foot plate. in the event that the mandible distractor becomes disengaged from the proximal foot plate during device implantation, surgical delay may occur if another device is not available in the surgical suite. if the mandible distractor becomes disengaged from the proximal foot plate after procedure, a repeat surgery may be required to replace the mandible distractor/foot plates. there may be a risk of local infection as a result of repeat surgery caused by the disengagement since the product is in the oral cavity.
  • Acción
    Johnson & Johnson Medical is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correctio...
  • Modelo / Serial
    Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)Part Numbers: 487.962, 487.963, 487.964, 487.965, 487.974, 487.975All lots affectedARTG Number: 183673
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes