Events

Rappel de Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System

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-01090-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-11-12
  • 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-01090-1
  • 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
    Upon evaluation, depuy synthes discovered that certain lots of the screw inserter may potentially be etched with an incorrect graphic. the orientation of the etched image of the oblique angle on the screw inserter may be reversed which does not correspond to the tip of the angle of the instrument. this could result in the oblique cut at the lateral end of the screw being at a 90 degree angle to the lateral cortex.It is possible that the user would identify the final lateral oblique angle is not in the desired position, which could result in repositioning the screw within the nail so that the oblique angle of the screw is flush with the bone. the screw is designed to go in either orientation to allow proper depth placement of screw which is a critical factor for the success of the implant.
  • Action
    JJM is requesting users inspect all devices in their possession and to quarantine all non-conforming stock prior to their return to JJM. This action has been closed-out on 29/08/2016.

Device

Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing System
  • Modèle / numéro de série
    Screw Inserter for TFN-Advanced (TFNA) Proximal Femoral Nailing SystemPart number: 03.037.025Lot Numbers: 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, 9319407ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes