Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00799-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-08-19
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00799-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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