Events

Rappel de Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Synthes 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-2014-RN-00611-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-06-06
  • 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-2014-RN-00611-1
  • 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 packaging for the selected part and lot numbers of the guide wire ø 3.2 mm, length 400 mm were mislabelled with an incorrect material. the label incorrectly declares 'molybdenum' instead of wolfram and nickel as alloyed elements. the correct label should indicate “cocrwni alloy”. during the normal course of the surgery, the risk of adverse tissue reaction is decreased as the guide wire is not retained in the body after the procedure is completed. in the case of a broken guide wire, a fragment may be retained after surgery. in this case, a patient with sensitivity to nickel could develop a moderate adverse tissue reaction.
  • Action
    Customers are advised to immediately isolate the affected stock for returning to Synthes Australia.

Device

Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)
  • Modèle / numéro de série
    Guide Wire diameter 3.2mm, length 400mm (Fixation nail guidewire)Part Number: 357.399Lot Numbers: 7560756, 7584396, 7594896, 7560829, 7562800, 7589236, 7594058, 7583667, 7589696 and 7594057 ARTG Number: 203637
  • Manufacturer
    Synthes Australia Pty Ltd

Manufacturer

Synthes Australia Pty Ltd