Events

Rappel de DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)

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-00976-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-09-10
  • 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-00976-1
  • 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) is issuing a device recall of the charnley pin retractor & handle set due to the potential for breakage of the small extraction peg away from the pin. analysis of the pegs from the above affected lots identified the existence of microscopic cracks in the weld region. this could lead to decreased strength and a greater risk of instrument fracture under what would be normally acceptable conditions.
  • Action
    Johnson & Johnson Medical Pty. Ltd. (JJM) is requesting the affected customer to inspect their inventory and quarantine the affected stock. JJM is making arrangements for a courier pick-up (free of charge) of the affected product and is issuing a credit note. This action has been closed-out on 07/06/2016.

Device

DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)
  • Modèle / numéro de série
    DePuy Charnley Pin Retractor & Handle Set (orthopaedic hip joint replacement instrument)Part Number: 962004000Lot Numbers: OSA-149328, OSA-161157, OSA-181610ARTG Number: 137164
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia