Events

Rappel de Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Device Technologies Australia 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-00154-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-03-24
  • 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-00154-1
  • 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
    Device technologies australia has become aware that the packaging of the cup removal instruments may not provide a sufficient safety barrier when handling and transporting instruments.
  • Action
    The distributors are advised to identify and isolate affected product from use, making sure to handle carefully. A Device Technologies Australia Pty Ltd's representative will contact the distributor to organise a time to repackage affected stock at their site. This re-packaging will consist of: ? Adding a new black cap to the blade ? Wrapping the blade head in bubble wrap and securing with tape. ? Re-packaging in the original packaging ? Addition of a warning sticker ? Addition of compliant labelling

Device

Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minim...
  • Modèle / numéro de série
    Cup Removal Instruments (Reusable surgical instrument used to remove an acetabular cup with minimal loss of bone)Multiple Product Codes
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd