Events

Rappel de Sciatic Nerve Retractors

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-2018-RN-00334-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2018-04-18
  • 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-2018-RN-00334-1
  • 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 and johnson has identified the potential for micropores to form on the hollow handle of the sciatic nerve retractor. the pores may increase in size, allowing fluid to enter the hollow handle. discoloration and moisture were identified within the packaging of the affected lots of sciatic nerve retractors indicating that these pores may be present in the affected devices.Even with diligent reprocessing/sterilisation of the retractor, subsequent patients may be at risk for infection and adverse tissue reaction due to retained fluids leaking out during use.
  • Action
    Johnson and Johnson are advising users to inspect stock and return any affected product as soon as possible.

Device

Sciatic Nerve Retractors
  • Modèle / numéro de série
    Sciatic Nerve Retractors Part Numbers: 03.100.013, 03.100.014Lot Numbers: T140390, T140675, T140677 ,T145819, T140566, T140673, T151369ARTG Number: 296161Johnson & Johnson Medical t/a DePuy Synthes - Wound retractor, intermediate/deep
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes

Manufacturer

Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes