Events

Retiro De Equipo (Recall) de Cross-Link Clamp for Rods, 6.0 mm

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-00290-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-03-31
  • 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-00290-1
  • 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 pre-assembled cross-link clamp is used with 6mm longitudinal rods and 3.5mm transverse rods to provide additional rotational stability to long posterior thoracolumbar constructs. due to an error in production, the affected pre-assembled cross-link clamp cannot be securely attached to 6mm longitudinal rods. if the clamp does not tighten appropriately there is potential for surgical delay.
  • Acción
    Johnson & Johnson Medical is requesting end users to immediately identify and quarantine all unused products listed. Potentially affected product is to be returned to Johnson & Johnson Medical as soon as possible. This action has been closed-out on 4/08/2016.

Device

Cross-Link Clamp for Rods, 6.0 mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes