Events

Rappel de Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Mathys Orthopaedics 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-2013-RN-01020-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-10-17
  • 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-2013-RN-01020-1
  • 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
    Mathys ltd bettlach has been notified of an incident in switzerland where the optimys opening broach broke intraoperatively and the fragment was left in the bone. in the course of the investigations, it became apparent that the opening broach bent may exhibit surface defects in the hewn portion which may favour breakage in case of non-compliant usage.
  • Action
    Replacement products made of more suitable material are being manufactured and will be provided to customers as soon as they become available. In the interim, customers are reminded on the correct usage of the device according to the surgical technique.

Device

Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)
  • Modèle / numéro de série
    Optimys Opening Broach Bent (Reusable surgical instrument used for opening the medullary canal)Article Number: 51.34.0079Lot Number: 6054883ARTG Number: 184413
  • Manufacturer
    Mathys Orthopaedics Pty Ltd

Manufacturer

Mathys Orthopaedics Pty Ltd