Events

Rappel de E.T.O.I.L.E sytem 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-2016-RN-01625-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-06
  • 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-01625-1
  • 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
    Following a customer complaint about the e.To.I.L.E extension table, an analysis of the device showed a failure due to an abnormal wear in the locking system of the external rotation. a failure of the rotation locking mechanism would mean that the rotation of the leg would not be able to be maintained and may have the following consequences:- an increase in the surgery timeline if the incident occurs at the beginning of the surgery.- a risk of injury for the patient if the incident occurs during surgery.There have been no reported patient injuries. as a precautionary measure, amplitude decided to set up a preventive maintenance on all the e.T.O.I.L.E systems on the market.
  • Action
    Amplitude is arranging for the return of all devices for preventative maintenance. Replacement devices will be provided as necessary.

Device

E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)
  • Modèle / numéro de série
    E.T.O.I.L.E sytem extension table (leg holder)(used in total hip arthroplasty)Reference: 3-0499902Serial Numbers: 1500044, E1210021, E1210022, E1210023ARTG Number: 216762
  • Manufacturer
    Amplitude Australia Pty Ltd

Manufacturer

Amplitude Australia Pty Ltd