Events

Rappel de Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)

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-2016-RN-00934-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-14
  • 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-2016-RN-00934-1
  • 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
    Stryker has received product complaints stating that a rivet or rivets came off an exeter non v40 rasp handle. these complaints are associated with the exeter rasp handles with either the green or black plastic lever, manufactured between january 1995 and october 2005. the current exeter v40 rasp handles with a metallic lever are not within the scope of this recall. in the event that a rivet comes off the exeter non v40 rasp handle during surgery there are several hazards that would increase surgical time. these include locating the fragment, retrieving a sterilised replacement rasp handle and potentially an intra-operative x-ray if required. the exeter non v40 rasp handle may continue to function without the rivet.
  • Action
    Stryker is advising users to inspect inventory and quarantine and remaining units of the affected product for return. This action has been closed out on 15 June 2017.

Device

Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter fem...
  • Modèle / numéro de série
    Exeter Non V40 Rasp with plastic handle (reusable instrument used for the implantation Exeter femoral hip system)Product Code: 0930-9-003All lots manufactured between January 1995 and October 2005ARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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