Events

Rappel de Arthrex ITD Articulating Arm 300 + 350MM

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-2016-RN-01192-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-09-12
  • 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-01192-1
  • 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
    The manufacturer has identified that the rivets of the rotation on the item ‘vesa 75 / 100 adapter connection with rotation’, which is an integral part of the articulating arm 300 + 350mm, may not have been executed in accordance with the relevant standards. the rivets may be weak. in exceptional cases, the connection panel may become loose or detached when subjected to continuous operation. this may potentially endanger the safety of patients, users or third parties. there have been no reported cases of loss or damage in the field related to this issue.
  • Action
    Device Technologies is advising users that a repair kit will be provided to all affected customers to correct the device. This action has been closed-out on 18/05/2017.

Device

Arthrex ITD Articulating Arm 300 + 350MM
  • Modèle / numéro de série
    Arthrex ITD Articulating Arm 300 + 350MMProduct Code: AR-5995SAS-FP30Serial Numbers: 001-061736, 001-061740, 001-061742, 001-061745 ARTG Number: 207096
  • Manufacturer
    Device Technologies Australia Pty Ltd

Manufacturer

Device Technologies Australia Pty Ltd