Events

Rappel de Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)

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-00806-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-15
  • 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-00806-1
  • 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 fastener on the mandible distractor may become prematurely separated from the proximal foot plate. in the event that the mandible distractor becomes disengaged from the proximal foot plate during device implantation, surgical delay may occur if another device is not available in the surgical suite. if the mandible distractor becomes disengaged from the proximal foot plate after procedure, a repeat surgery may be required to replace the mandible distractor/foot plates. there may be a risk of local infection as a result of repeat surgery caused by the disengagement since the product is in the oral cavity.
  • Action
    Johnson & Johnson Medical is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correctio...
  • Modèle / numéro de série
    Mandible Distractor and Proximal Footplate (used to stabilise bone and lengthen for the correction of congenital deficiencies or post-traumatic defects)Part Numbers: 487.962, 487.963, 487.964, 487.965, 487.974, 487.975All lots affectedARTG Number: 183673
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes