Events

Retiro De Equipo (Recall) de SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical Pty Ltd T/A Depuy Australia.

¿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-00938-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-14
  • 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-00938-1
  • 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
    Testing has indicated that the spiralok anchors may not be as robust compared to other similarly indicated anchors and is removing it from the market.
  • Acción
    Customers are requested to quarantine affected stock and contact the sponsor to organise return. Physicians are advised to report any patient events involving fractured anchors to the sponsor.

Device

SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)
  • Modelo / Serial
    SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery)Product Codes: 222960, 222961, 222962, 222963, 222985, 222986, 222987 & 222988ARTG Numbers: 136226, 136227, 136226, 136227, 123272, 123017, 123272 & 123017
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia