Retiro De Equipo (Recall) de DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)

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 Australia.

¿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
  • ID del evento
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Johnson & johnson medical pty. ltd. (jjm) is issuing a device recall of the charnley pin retractor & handle set due to the potential for breakage of the small extraction peg away from the pin. analysis of the pegs from the above affected lots identified the existence of microscopic cracks in the weld region. this could lead to decreased strength and a greater risk of instrument fracture under what would be normally acceptable conditions.
  • Acción
    Johnson & Johnson Medical Pty. Ltd. (JJM) is requesting the affected customer to inspect their inventory and quarantine the affected stock. JJM is making arrangements for a courier pick-up (free of charge) of the affected product and is issuing a credit note. This action has been closed-out on 07/06/2016.