Events

Rappel de Apex 10mm reamer

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Global Orthopaedic Technology 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-2015-RN-00419-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-05-18
  • 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-2015-RN-00419-1
  • 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
    Sequential reaming of the patient's femur was being carried out during a total hip replacement(thr) procedure. following the use of the 8mm reamer, the 10mm reamer was introduced. during reaming the bottom of the reamer broke off while lodged in the patients femur, approximately 40mm below the resection level. a distal window was cut into the femur, and the broken section of the reamer removed. under torque the reamer broke at a weld joint. the joint was insufficiently strong.This action is undertaken prior to notifying the tga.
  • Action
    Global Orthopaedics Technology has retrieved, quarantined and returnign all affected reamers to the manufacturer. The manufacturer, Omni Life Sciences, has obsoleted the design used for the affected reamers.

Device

Apex 10mm reamer
  • Modèle / numéro de série
    Apex 10mm reamer ARTG Number: 183711CER-227: 16-May-2011- 8.5mm REAMER Lot L0805CER-257: 10-Aug-2011 - 16mm REAMER Lot L0805CER-358: 18-0ct -2012 - 10mm REAMER Lot L0805
  • Manufacturer
    Global Orthopaedic Technology Pty Ltd

Manufacturer

Global Orthopaedic Technology Pty Ltd