Events

Rappel de Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)

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-01137-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-26
  • 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-01137-1
  • 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 orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant. upon investigation, it was determined that the press fit between the threaded stud and the handle shaft assembly for the trident universal impactor/positioner may lead to the gradual protrusion of the threaded stud over time. this may result in a delay in surgery, fracture or pain associated with the implant loosening.
  • Action
    Stryker is advising users to inspect inventory and quarantine affected product for return. This action has been closed out on 16 June 2017.

Device

Universal Impactor/Positioner (used to introduce and extract compatible universal window trials a...
  • Modèle / numéro de série
    Universal Impactor/Positioner (used to introduce and extract compatible universal window trials and acetabular cups into the prepared acetabulum during total hip arthroplasty)Item Number: 2101-0200Multiple Lot Numbers affectedARTG Number: 140892
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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