Events

Rappel de Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished 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 Stryker 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-2013-RN-00652-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-07-03
  • 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-00652-1
  • 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
    When removing the aliquot catheter from the needle during a vertebroplasty procedure, there have been reported cases of the catheter breaking. this has been attributed to bending the catheter during its retraction from the needle.
  • Action
    Stryker is providing end users with additional information and warnings to reduce the chance of the catheter breaking due to bending during retraction. The device instructions for use will be updated to reflect this information.

Device

Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable syntheti...
  • Modèle / numéro de série
    Aliquot Syringe Delivery System Kits (orthopaedic surgical kit, used to place injectable synthetic cortical bone void filler in weak or diminished bone)Catalogue number: 20900501Lot numbers: A1203024, A1205018, A1206005, A1109035ARTG Number: 140434
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA