Events

Retiro De Equipo (Recall) de SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part of SIGMA Knee System)

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
    Recall
  • ID del evento
    RC-2013-RN-00799-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2013-08-19
  • 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-2013-RN-00799-1
  • 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 compatibility chart on the product label and or reference chart literature/poster indicates that the size 6 posterior stabilized (ps) femoral component is compatible with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts. the size 6 ps femoral component is not cleared for use with the size 4 posterior stabilized (ps) tibial inserts and size 4 stabilized plus (sp) tibial inserts, and should not be implanted with either of these size 4 insert.
  • Acción
    Existing OR Reference Charts on posters should be discarded and replaced with revised OR Reference Charts, which will be supplied to the customers by JJM sales representatives.

Device

SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part o...
  • Modelo / Serial
    SIGMA Fixed Bearing Tibial Inserts - PLI, Cruciate Retaining, Posterior Stablised (used as part of SIGMA Knee System)Multiple model numbers affectedAll lots manufactured after July 2010ARTG Numbers: 138289, 98092
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia