Events

Retiro De Equipo (Recall) de VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

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-00733-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-08-13
  • 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-00733-1
  • 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
    This action is being initiated because the last hole on the veptr caudal rib supports, subject to this recall, may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
  • Acción
    Customers are asked to immediately check their inventory to determine if their facility has any affected product and to subsequently quarantine these units prior to returning them to JJM. This action has been closed-out on 29/08/2016.

Device

VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes