Events

Rappel de Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affected

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-00068-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-01-22
  • 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-00068-1
  • 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 cement mixer used to prepare cement for surgery has been identified to not turn properly. the event may be described as the mixer being 'jammed' or 'stuck' and not able to turn, which could result in surgical delay in order to prepare another kit, or the inability to complete the procedure if an additional kit is not available; thereby exposing the patient to additional anaesthesia in another surgical procedure.
  • Action
    Customers are being advised to quarantine any affected products and return the products for a credit.

Device

Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers...
  • Modèle / numéro de série
    Confidence Spinal Cement System 11cc Plus Kit, Confidence Spinal Cement System KitAll lot numbers affectedProduct Codes: 283910000 and 283913000
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd