Events

Rappel de Multiple Suture Anchors: Various models of HEALICOIL, TWINFIX, BIORAPTOR, FOOTPRINT Suture Anchors (Used to attach the end of a synthetic or natural ligament to bone)Also Supplied separately and as part of the surgical arthroscopic procedure kit which is labelled with the suture model name.

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-2012-RN-00821-3
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2012-08-14
  • 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-2012-RN-00821-3
  • 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
    The reason for this product recall is due to a packaging issue. specifically, pin holes have been identified in a small number of pouches, which constitutes a breach of the sterile barrier.
  • Action
    Customers to remove affected units from use and contact the Sponsor to arrange for replacement stock.

Device

Multiple Suture Anchors: Various models of HEALICOIL, TWINFIX, BIORAPTOR, FOOTPRINT Suture Anchor...
  • Modèle / numéro de série
    Multiple Suture Anchors: Various models of HEALICOIL, TWINFIX, BIORAPTOR, FOOTPRINT Suture Anchors (Used to attach the end of a synthetic or natural ligament to bone)Also Supplied separately and as part of the surgical arthroscopic procedure kit which is labelled with the suture model name.Multiple catalogue numbers affected All lot numbers affectedARTG Numbers: 109451 and 120338
  • Classification du dispositif
    Orthopedic Devices
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd