Retiro De Equipo (Recall) de DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable) DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various length

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Synthes Australia Pty Ltd.

¿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-2013-RN-00324-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-04-12
  • País del evento
  • Fuente del evento
    DHTGA
  • 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
    Synthes has two couplings in place for the dhs/dcs screws, standard with teethed recess and octagonal recess. the pictogram on the labels of the articles shows the wrong coupling. all other information on the label (e.G. coupling description in words) is correct.
  • Acción
    Depuy Synthes is recalling the affected lots and is replacing them with unaffected units.

Device

  • Modelo / Serial
    DHS/DCS Screw, sterile (Orthopaedic bone screw, non bio-degradable)DHS/DCS Screw 12.5mm, octagonal coupling, stainless steel, sterile, various lengthPart number: 280.XXXSDHS/DCS Screw, Titanium Alloy (TAN), sterile, various lengthPart number: 480.XXXS Multiple lot numbers affected.ARTG number: 157068
  • Manufacturer

Manufacturer