Events

Rappel de Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes.

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-00216-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-16
  • 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-00216-1
  • 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
    It was discovered that during blade insertion, the tfna guide sleeve has the potential to jam inside of the affected aiming arms which may delay disassembly and/or removal of the instruments.
  • Action
    Johnson & Johnson Pty Limited is providing end users with work around instructions to be used until replacement stock is available. In the event that the user has difficulty with the Aiming Arm/Guide Sleeve Assembly the user can disassemble via two methods: 1) Turn the Guide Sleeve counter clockwise within the Aiming Arm to clear the jamming. This operation can be performed manually and requires relatively low force and no additional instrumentation. 2) Disassemble the Aiming Arm/Guide Sleeve assembly as one unit by disengaging the Aiming Arm coupling screw from the Insertion Handle. The instruments can then be disassembled for cleaning using the technique described in 1). Johnson & Johnson Pty Limited will provide replacement product by 1 May 2015. This action has been closed-out on 17/08/2016.

Device

Aiming Arm 125deg and Aiming Arm 130deg for TFN-ADVANCED (TFNA) System(Orthopaedic surgical guide)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes