Events

Rappel de VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

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-00733-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-08-13
  • 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-00733-1
  • 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
    This action is being initiated because the last hole on the veptr caudal rib supports, subject to this recall, may be partially formed. fully lengthening the construct to the partially formed last hole may result in mechanical failure of the construct due to extension bar breakage, which could require unplanned surgical intervention to exchange components. in addition to the risks inherent to re-operation, potential effects on the patient could also include pain, loss of deformity correction, and/or soft tissue/visceral injury.
  • Action
    Customers are asked to immediately check their inventory to determine if their facility has any affected product and to subsequently quarantine these units prior to returning them to JJM. This action has been closed-out on 29/08/2016.

Device

VEPTR Vertical Expandable Prosthetic Titanium RibCaudal Rib Supports (Rib-to-Rib Construct Only)

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes