Events

Retiro De Equipo (Recall) de DePuy CMW 2 Gentamicin Bone Cement 20 g

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.

¿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-2014-RN-00151-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-02-13
  • 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-2014-RN-00151-1
  • 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 amount of gentamicin detailed on the unit outer carton label is incorrectly stated as 1.0 m.I.U. (million international units). this should be labelled 0.5 m.I.U. information on the foil pouch and ifu is correct. the composition of the mislabelled bone cement complies with the product specifications and the cement functions according to design intent. the affected lots should be used in the normal manner in accordance with the ifu, and the gentamicin content on the outer carton label for these batches should be disregarded.
  • Acción
    Johnson & Johnson Medical are advising users to continue to follow the Instructions for Use (IFU).

Device

DePuy CMW 2 Gentamicin Bone Cement 20 g
  • Modelo / Serial
    DePuy CMW 2 Gentamicin Bone Cement 20 g Part Number: 3325020 Lot Numbers: 3590475, 3607803, 3620321 and 3625505
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd