Events

Retiro De Equipo (Recall) de Azure

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Orthofix, Inc.

¿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
    66660
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1089-2014
  • Fecha de inicio del evento
    2013-10-29
  • Fecha de publicación del evento
    2014-02-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-12-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122914
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Causa
    There is a possibility that the locking mechanism of the azure anterior cervical plate may fracture during or after implantation.
  • Acción
    Orthofix sent a Urgent Medical Device Recall Notification dated October 29, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediate Action: 1. Immediately cease any further distribution or use of the AZURE" plates. 2. Notify your surgeons and staff customers that Azure" plates cannot be used and are to be returned to Orthofix. at no cost to you, see Instructions below. 3. Please complete the attached reply form indicating that you have received this letter. Product Return Instructions: To return the Azure plates, please follow these Instructions. 1. Check you inventory of Azura Implant Trays.. 2. Complete the attached form with the quantity you are returning. 3. Contact your local Orthofix representative or Orthofix customer service representative at 888--298-5700 for return instructions and shipment information and replacement with a different Orthofix Anterior Cervical Plate System. .

Device

Azure
  • Modelo / Serial
    86-01xx, 86-02xx, 86-03xx, 86-04xx, 86-05xx  All lot numbers manufactured to date
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: USA (nationwide) and the country of Germany.
  • Descripción del producto
    Azure Anterior Cervical Plate System, 2-Level Plate, 36 mm, Implant Grade Titanium and Nitinol, Orthofix Inc., RX Only || The Azure Anterior Cervical Plate System is a temporary implant, intended for anterior fixation to the cervical spine from C2 to C7 and is indicated for: A. Degenerative disc disease, B. Spondylolisthesis, C. Trauma, D. Spinal Stenosis, E. Deformities, F. Tumor, G. Pseudoarthrosis, and H. Revision of previous surgery. The Azure Anterior Cervical Plate System is comprised of a variety of non-sterile, single use, titanium alloy and nitinol components. The system is attached to the anterior aspect of the vertebral body by means of screw to to the cervical spine.
  • Manufacturer
    Orthofix, Inc

Manufacturer

Orthofix, Inc
  • Dirección del fabricante
    Orthofix, Inc, 3451 Plano Pkwy, Lewisville TX 75056-9453
  • Empresa matriz del fabricante (2017)
    Orthofix International Nv
  • Source
    USFDA