Events

Retiro De Equipo (Recall) de Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kit, Fracture Adapter Tray Screws and Octane-C Intervertebral fusion devices (intended for Primary and Reverse Total Shoulder joint Arthroplasty)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Exactech 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-00892-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-09-05
  • 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-00892-1
  • 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
    The device labelling identifies the affected parts as having a ten year shelf life, however the packaging configuration that was used qualifies it as a five year shelf life.This recall action was not notified to the tga before it was initiated by exactech australia.
  • Acción
    Cease sale, use and further distibution of the affected products and return the stock to Exactech Australia.

Device

Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kit, Fr...
  • Modelo / Serial
    Equinoxe Reverse Compression Screws, Replicator Plates, Locking Screws, Compression Screw Kit, Fracture Adapter Tray Screws and Octane-C Intervertebral fusion devices (intended for Primary and Reverse Total Shoulder joint Arthroplasty)
  • Manufacturer
    Exactech Australia

Manufacturer

Exactech Australia