Events

Rappel de Straight Adjustable Gastric Band Product Code: 2200X & BD2XV

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.

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-01030-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-10-21
  • 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-01030-1
  • 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 manufacturer ethicon endo-surgery, has determined that the straight adjustable gastric band was unable to pass the internal test for 'force to close'. as a result surgeons may experience difficulty in locking the straight gastric band buckle during implantation. once the product is locked, the gastric band will remain in place and will function as intended.
  • Action
    JJM is requesting customers to return affected product for a credit note. The Straight Adjustable Gastric Band will not be available in the market in the future.

Device

Straight Adjustable Gastric Band Product Code: 2200X & BD2XV
  • Modèle / numéro de série
    Straight Adjustable Gastric Band Product Code: 2200X & BD2XVAll lot numbers affectedARTG Number: 94766
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd