Events

Rappel de Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Global Orthopaedic Technology 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-2015-RN-00002-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-02-10
  • 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-00002-1
  • 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
    Intrinsic therapeutics inc has identified a manufacturing defect affecting a select number of batches of the delivery tool (instrument). the defect can cause the instrument to break under stress during surgery. this defect does not impact the implant, its performance or possible safety of patients.
  • Action
    1. Quarantined all stock on hand in the Global Orthopaedic Technology warehouse; 2. All Stock Recalled and physically had returned to Global Orthopaedic Technology warehouse that was on consignment with 1 hospital and on loan with second hospital. 3. All product recalled, quarantined and returned to the manufacturer. This action was undertaken prior to consultation with the Therapeutic Goods Administration.

Device

Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy...
  • Modèle / numéro de série
    Prosthesis, internal, spine, disc(The prosthesis is intended as an adjunct to a lumbar discectomy procedure as a means to maintain the relative position of nucleus within the disc space, thereby reducing the risk of a recurrent herniation.)ARTG Number: 182175
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd