Events

Rappel de E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in 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 Amplitude 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-2017-RN-00859-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-07-12
  • 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-2017-RN-00859-1
  • 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
    In december 2016, a recall action was undertaken (rc-2016-rn-01625-1) following customer complaints about the e.To.I.L.E extension table regarding abnormal wear in the locking system of the external rotation. at this time, the manufacturer, amplitude were to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.An additional analysis of the e.To.I.L.E extension table has been performed and concludes that a design modification of the locking system is recommended to reduce the risk of lack of locking in external rotation. therefore, amplitude has decided to exchange all the e.T.O.I.L.E systems on the market for systems manufactured according to a new design.
  • Action
    As a precautionary measure, Amplitude has decided to exchange all the E.T.O.I.L.E systems on the market by systems manufactured according to new design.

Device

E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)
  • Modèle / numéro de série
    E.T.O.I.L.E system – E.TO.I.L.E extension table (leg holder used in total hip arthroplasty)Reference Number: 3-0499902Serial Numbers: 159722, 159724, 167258, 169723 and 169979ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd