Events

Rappel de DePuy Synthes Confidence Kit Spinal Cement 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 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-2017-RN-01534-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-12-20
  • 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-2017-RN-01534-1
  • 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
    (jjm) is initiating a recall of depuy synthes confidence kit spinal cement system has received reports where the confidence cement products were difficult to visualize on x-ray, or could not be visualized on x-ray. it was identified that the confidence cement kit lots impacted by this field action may contain confidence cement products with incorrect amounts of contrast medium. the contrast medium allows for visualisation of the cement under x-ray imaging.
  • Action
    Johnson & Johnson is advising users to inspect stock and quarantine any remaining units of the affected product for return.

Device

DePuy Synthes Confidence Kit Spinal Cement System
  • Modèle / numéro de série
    DePuy Synthes Confidence Kit Spinal Cement SystemProduct Number: 283910000Confidence Plus Kit Spinal Cement System, 11ccLot Numbers: 133824, 145665, 145664, 135476, 152906Confidence Kit Spinal Cement SystemLot Numbers: 133831, 145669, 152908, 153883, 154956, 154957ARTG Number: 211565
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes