Events

Rappel de DePuy S-ROM Noiles Rotating Hinge Femur with Pin

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 Australia.

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-2014-RN-00939-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-08-27
  • 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-2014-RN-00939-1
  • 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 march, 2014, johnson & johnson medical pty. ltd (jjm) issued recall for product correction letter (tga ref.: rc-2014-rn-00355-1) for the s-rom noiles rotating hinge femur with pin devices as the company had identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for both the femur and the hinge pin. the new packaging design is complete and products are available with the new packaging. therefore, johnson & johnson medical pty ltd is recalling the products with the previous packaging from the market.
  • Action
    Customers are advised not to use the affected inventory. Replacement product with the new packaging will be supplied for the affected stock. This action has been closed-out on 06/06/2016.

Device

DePuy S-ROM Noiles Rotating Hinge Femur with Pin
  • Modèle / numéro de série
    DePuy S-ROM Noiles Rotating Hinge Femur with Pin Product Codes: 623401L, 623401R, 623411L, 623411R, 623421L, 623421RAffected lots: 314827, 464645, 438249 & 378650ARTG number: 219088
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia