Events

Rappel de Brainlab Offset Cup Impactor Universal (blue handle)

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-2017-RN-00178-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-07
  • 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-2017-RN-00178-1
  • 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
    An issue has been detected that when the brainlab offset cup impactor universal (blue handle) is reprocessed in a sterilisation tray as described in the current brainlab cleaning, disinfection and sterilisation guide (revision 5.2 and previous versions), the device may not be determined as sterile. the required sterility assurance level (sal) of 10-6 can only be achieved if the device is individually wrapped for sterilisation. if a non-sterile brainlab offset cup impactor universal (blue handle) is used during a surgical procedure to implant an acetabular cup, contaminated residues on the product surface could, directly or indirectly, enter the patient’s body, potentially leading to an infection. at this stage, there have been no reports of affected patients due to this issue.
  • Action
    Brainlab is advising users to follow the sterilisation instructions in the current version (BL-IL-60960-69ML Rev. 1) of the IFU. Users are reminded that in addition to following the other instructions in the IFU, the Offset Cup Impactor Universal (blue handle) must be sterilized in an individually wrapped configuration.

Device

Brainlab Offset Cup Impactor Universal (blue handle)
  • Modèle / numéro de série
    Brainlab Offset Cup Impactor Universal (blue handle)Catalogue Numbers: 52856, 52856AARTG Number: 121094
  • Manufacturer
    Brainlab Australia Pty Ltd

Manufacturer

Brainlab Australia Pty Ltd