Events

Rappel de Cross-Link Clamp for Rods, 6.0 mm

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-00290-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-31
  • 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-00290-1
  • 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 pre-assembled cross-link clamp is used with 6mm longitudinal rods and 3.5mm transverse rods to provide additional rotational stability to long posterior thoracolumbar constructs. due to an error in production, the affected pre-assembled cross-link clamp cannot be securely attached to 6mm longitudinal rods. if the clamp does not tighten appropriately there is potential for surgical delay.
  • Action
    Johnson & Johnson Medical is requesting end users to immediately identify and quarantine all unused products listed. Potentially affected product is to be returned to Johnson & Johnson Medical as soon as possible. This action has been closed-out on 4/08/2016.

Device

Cross-Link Clamp for Rods, 6.0 mm

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes