Events

Rappel de HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Integra Neurosciences 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-2014-RN-00200-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-02-24
  • 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-2014-RN-00200-1
  • 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
    Integra neurosciences has recently identified, through an internal evaluation, a risk of damage to the package (external pouch) of the hintegra total ankle prosthesis tibial and talar components during shipping/handling. this damage might lead to a breakage of the sterility barrier of this external pouch, thus posing the risk of a potential patient infection. the risk for an adverse patient consequence has been determined to be not likely based on the manufacturer’s health hazard evaluation.
  • Action
    Integra trained representatives will be performing an inspection of the affected components at the healthcare facility before each surgery by following a verified inspection process. This will assure that only products without damages external pouches are used in surgeries.

Device

HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)
  • Modèle / numéro de série
    HINTEGRA Standard and Revision tibial and talar components (Total Ankle Prosthesis)Multiple Catalogue Numbers affected All unexpired lotsARTG Number: 173960
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd