Events

Retiro De Equipo (Recall) de VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)

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-01147-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2012-11-13
  • 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-01147-1
  • 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
    During insertion of viper large diameter long screws in high-torque circumstances (such as placement into the ilium) the screw shank has the potential to separate from the polyaxial head. the disassembly of the screw requires that the shank be removed either via the drive feature in the shank or via alternate methods.
  • Acción
    Quarantine and return affected products to Johnson & Johnson Medical.

Device

VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisa...
  • Modelo / Serial
    VIPER 8, 9 & 10mm Large Diameter Polyaxial Screws, Lengths 70, 80 & 100 mm (To provide immobilisation and stabilisation of spinal segments in the treatment of instabilities or deformities of the thoracic, lumbar, and sacral spine)Multiple Product Codes All Lot NumbersARTG Numbers: 145290 & 178040
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd T/A Depuy Australia

Manufacturer

Johnson & Johnson Medical Pty Ltd T/A Depuy Australia