Events

Rappel de Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)

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-00276-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-03-27
  • 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-00276-1
  • 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 label of affected product lists the incorrect sterilisation and expiration date. incorrect expiration date listed on label: 2018-06actual expiration date: 2017-07incorrect sterilisation date listed on label: 2014-06actual sterilisation date: 2013-10if the affected lot number were to be used past the expiration date of july 2017, malunion/non-union may occur.
  • Action
    Johnson & Johnson Medical Pty Limited (JJM) is advising customers that they can return the affected stock if they choose to do so. This action has been closed-out on 02/06/2016.

Device

Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium i...
  • Modèle / numéro de série
    Angular Stable Locking System (ASLS), 5.0 mm, Resorbable (Used with Synthes cannulated titanium intramedullary nails)Part Number: 08.025.044.01SLot Number: 8586243ARTG Number: 168395
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes