Events

Retiro De Equipo (Recall) de CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Integra Neurosciences 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-2014-RN-00306-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-03-13
  • 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-2014-RN-00306-1
  • 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
    Integra lifesciences has identified that some lots of 23 khz sterile torque wrenches contain wrenches that will only fit 36 khz cusa handpiece tips. the green colour code and size printed on the wrenches are correct for a 23 khz wrench, but the affected wrench size insert is smaller than it should be and will only fit a 36 khz cusa tip.
  • Acción
    Integra is requesting end users to determine if they have any units from the affected lot. If the outer box has a green dot sticker the torque wrench can be used. If the box does not have a green dot sticker end users are requested to quarantine the unit. An Integra sales representative will arrange for the affected units to be inspected. In the event that an inspection cannot be undertaken in a reasonable time replacement units will be arranged.

Device

CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)
  • Modelo / Serial
    CUSA Excel+ Sterile Torque Disposable Wrench (23kHz)Catalogue Number: C5601Lot Numbers: 1132424, 1132883, 1132884, 1133453, 1133454, 1133455, 1134067, 1134675, 1134873, 1135014ARTG Number: 151 502
  • Manufacturer
    Integra Neurosciences Pty Ltd

Manufacturer

Integra Neurosciences Pty Ltd