Events

Retiro De Equipo (Recall) 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.

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Smith & Nephew Surgical Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2012-RN-00821-3
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2012-08-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-00821-3
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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...
  • Modelo / Serial
    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
  • Clasificación del producto
    Orthopedic Devices
  • Manufacturer
    Smith & Nephew Surgical Pty Ltd

Manufacturer

Smith & Nephew Surgical Pty Ltd