Events

Rappel de Inserter f/TEN

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 Synthes.

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-2015-RN-00185-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-11
  • 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-2015-RN-00185-1
  • 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 affected lots of the inserter for titanium elastic nails (ten) may have the potential for breakage during use. it is important to note that the removal of the ten inserter would prevent the performance of emergency surgery, thus synthes gmbh is not requiring an immediate return of affected product(s).
  • Action
    JJM is providing work around instructions to prevent the breaking of the cross/transversal bar and jamming of the chuck. The manufacturer, Synthes GmbH, is in the process of developing the replacement & recovery plan for indicated devices and will contact their customers as replacements become available. This action has been closed-out on 06/06/2016.

Device

Inserter f/TEN

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes