Events

Rappel de Guide Sleeve, yellow for Trochanteric Fixation Nail 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-2016-RN-00877-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-07-04
  • 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-00877-1
  • 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 affected lots of the guide sleeves (part # 03.037.017) may have been manufactured with a slightly larger than specified outer diameter which could prevent the sleeve from going through the trochanteric fixation nail advanced (tfna) aiming arm properly.In the event that guide sleeve does not fit through the tfna aiming arm properly, a surgical delay may occur.
  • Action
    JJM DePuy Synthes is advising users to locate any potentially affected devices in their facility, and contact their JJM DePuy Synthes representative. The representative will conduct functional testing on all products subject to this notification to determine whether the device is conforming or not. Users should ensure every aiming arm is tested with every guide sleeve within their control and, upon completion, only return the device if the product does not pass the functional test.

Device

Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing System
  • Modèle / numéro de série
    Guide Sleeve, yellow for Trochanteric Fixation Nail Advanced (TFNA) Proximal Femoral Nailing SystemPart Number: 03.037.017Lot Numbers: 9066435, 9469298, 9542486, 9734863, 9763550, 9768881, 9768882, 9768884, 9768886ARTG Number: 153950
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes