Events

Rappel de Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Brainlab 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-01409-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-10-27
  • 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-01409-1
  • 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
    Brainlab has identified that one part of the femoral and tibial cutting block adapter base was made from incorrect material. consequently, neither biocompatibility nor corrosion resistance of these specific products can be ensured. if corrosion of the femoral and tibial cutting block adapter base occurs and is not detected by the user, and the device is used during surgery, corroded particles could, directly or indirectly, enter the patient’s body and potentially cause tissue irritation or a cytotoxic reaction of the patient. corrosion may also impair successful reprocessing of this device part, so that residue from previous surgeries could adhere to the corroded material. if not detected by the user and the device is used during surgery, germs could be transferred to the patient and lead to infection of the patient. brainlab has not received any reports of such corroded products having been used in surgery, nor of any effects on patients, due to this issue.
  • Action
    Brainlab is advising users to identify all affected units and remove them from clinical use. They are also advised to dispose them and that they will be provided with a replacement stock. This action has been closed-out on 23/05/2017.

Device

Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter Base
  • Modèle / numéro de série
    Brainlab Knee Navigation System: Femoral and Tibial Cutting Block Adapter BaseProduct Number: 41888-04Serial Numbers: ranging from1267114001 to 1267114070 and 1308615032ARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd