Events

Rappel de DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)

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-2013-RN-00482-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2013-06-04
  • 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-2013-RN-00482-1
  • 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
    Johnson & johnson medical pty ltd (jjm) has identified the potential for the reclaim reamer extension tabs to break off. 9 complaints worldwide since 2011 have been received reporting tab breakage. none of the complaints have indicated fragments were left in patients.
  • Action
    JJM is advising that users should check the condition of the reamer extension tabs on a regular basis, especially before and after usage. Any reamer extensions showing signs of cracks in the tab area or having broken or missing tabs, should be returned to JJM. Other devices from the affected lots may continue to be used until a design change is implemented and new devices are available.

Device

DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)
  • Modèle / numéro de série
    DePuy ReClaim Reamer Extension (Supplied as part of the ReClaim modular revision hip system kit)Part Number: 297500500Lot Numbers: J0111, J0211, J0411, J0611, J0911, J1211, NB12649, NB12650, NB12651, NB12652, NB12653, NB12654, NB12655, NB12656, NB23480, NB23481, NB3584, NB3586. NB3587, NB3588, NB3590, NB3591, NB5955, NB7894, NB8016, NB8017, NB8018, NB8019, NB8020, NB8021, NB8022, NB8023 ARTG Number: 191616
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia