Events

Rappel de Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the extremities)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Smith & Nephew Surgical Pty Ltd.

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-00897-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-22
  • 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-00897-1
  • 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
    Sterile k-wire and steinmann pin products are being recalled due to a packaging issue. specifically, there is a concern with the inner sterile pouch sealing of the product that may constitute a breach of the sterile barrier.
  • Action
    Smith & Nephew is advising users to inspect stock for affected product. Any affected product will be replaced by Smith & Nephew.

Device

Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the ...
  • Modèle / numéro de série
    Sterile K-Wire and Steinmann Pin Products (Typically used for temporary fixation of bones in the extremities)Multiple part and lot numbers affectedARTG number: 131082
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd