Events

Rappel de VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)

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-2012-RN-01147-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2012-11-13
  • 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-2012-RN-01147-1
  • 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
    During insertion of viper large diameter long screws in high-torque circumstances (such as placement into the ilium) the screw shank has the potential to separate from the polyaxial head. the disassembly of the screw requires that the shank be removed either via the drive feature in the shank or via alternate methods.
  • Action
    Quarantine and return affected products to Johnson & Johnson Medical.

Device

VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisa...
  • Modèle / numéro de série
    VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)Multiple Product Codes All Lot NumbersARTG Numbers: 145290 & 178040
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia