Events

Rappel de Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)

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-00897-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-09-15
  • 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-2015-RN-00897-1
  • 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
    In the affected lots of the application instrument for sternal zipfix :· the end cap may loosen, thus reducing the tension applied to the implant. · the end cap may detach, allowing the tensioning spring to also become detached, making the instrument non-functional.If the end cap is loose, the maximum tension applied to the implant is reduced and may lead to insufficient sternal bone reduction. if the tension coil spring detaches completely from the zipfix application instrument while closing the sternum, it is possible that the spring or nut could fall into the thoracic cavity and go undetected. if the nut/spring is retained in the thoracic cavity, adverse tissue reaction may occur. no such occurrence has been reported to date.
  • Action
    Customers are requested to immediately check their inventory to determine if the facility has any affected product and if so to quarantine those units prior to returning them to JJM for repair. This action has been closed-out on 05/09/2016.

Device

Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum follo...
  • Modèle / numéro de série
    Application Instrument for Sternal ZIPFIX(Sternal ZIPFIX is used for closure of the sternum following sternotomy to stabilize the sternum and promote fusion)Product Number: 03.501.080 Multiple Lot Numbers (see attached)ARTG Number: 153950
  • Classification du dispositif
    Orthopedic Devices
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes