Events

Retiro De Equipo (Recall) de Vu aPOD Intervertebral Body Fusion Device

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 Integra LifeSciences Corp..

¿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
    57100
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1475-2011
  • Fecha de inicio del evento
    2010-10-19
  • Fecha de publicación del evento
    2011-03-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-09-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95392
  • 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
    Spinal Vertebral Body Replacement Device - Product Code MQP
  • Causa
    The ifu provided with the device contains incorrect information in the indications for use section, stating the following: the theken spine vu a"pod intervertebral body fusion device is intended for use as a stand alone implant when used with the spinplate provided in the set.
  • Acción
    On 10/19/2010 the firm sent "URGENT : FIELD CORRECTION ACTION Letters to their customers. The letters identified the affected product and explained the reason for the recall. The letter also stated that the issue is not believed to have a health impact on patients. Physicians are asked to continue to exercise their clinical judgment with any periodic patient follow up. Attached to the letters were IFUs containing the correct information. Customers are to complete and return the enclosed Recall Acknowledgement Form per the instructions provided. Questions can be directed to Suzanne B. Wojcik, Sr. Dir Regulatory Affairs and Quality Assurance, at 330-835-8528.

Device

Vu aPOD Intervertebral Body Fusion Device
  • Modelo / Serial
    Model #'s: 21-11-2708, 21-21-2710, 21-23-3510, 21-40-0110, 21-LT-3508, 21-11-2710, 21-21-2712, 21-23-3512, 21-40-0120, 21-LT-3510, 21-11-2712, 21-21-2714, 21-23-3514, 21-40-0130, 21-LT-3512, 21-11-3108, 21-21-2716, 21-23-3516, 21-40-0131, 21-LT-3514, 21-11-3110, 21-21-3108, 21-23-3908, 21-40-0135, 21-LT-3516, 21-11-3112, 21-21-3110, 21-23-3910, 21-40-0140, 21-LT-3908, 21-11-3114, 21-21-3112, 21-23-3912, 21-40-0150, 21-LT-3910, 21-11-3116, 21-21-3114, 21-23-3914, 21-40-0160, 21-LT-3912, 21-11-3508, 21-21-3116, 21-23-3916, 21-40-0165, 21-LT-3914, 21-11-3510, 21-21-3508, 21-24-2708, 21-40-0170, 21-LT-3916, 21-11-3512, 21-21-3510, 21-24-2710, 21-40-0180, 21-TA-2708, 21-11-3514, 21-21-3512, 21-24-2712, 21-40-0190, 21-TA-2710, 21-11-3516, 21-21-3514, 21-24-2714, 21-40-0190-3, 21-TA-2712, 21-11-3908, 21-21-3516, 21-24-2716, 21-40-0200, 21-TA-2714, 21-11-3910, 21-21-3908, 21-24-3108, 21-40-0215, 21-TA-2716, 21-11-3912, 21-21-3910, 21-24-3110, 21-40-0245, 21-TA-3108, 21-11-3914, 21-21-3912, 21-24-3112, 21-40-0290, 21-TA-3110, 21-11-3916, 21-21-3914, 21-24-3114, 21-40-0400, 21-TA-3112, 21-20-2708, 21-21-3916, 21-24-3116, 21-40-0500, 21-TA-3114, 21-20-2710, 21-22-3112, 21-24-3508, 21-50-0100, 21-TA-3116, 21-20-2712, 21-22-3114, 21-24-3510, 21-50-0110, 21-TA-3508, 21-20-2714, 21-22-3116, 21-24-3512, 21-50-0210, 21-TA-3510, 21-20-2716, 21-22-3512, 21-24-3514, 21-50-0310, 21-TA-3512, 21-20-3108, 21-22-3514, 21-24-3516, 21-50-0410, 21-TA-3514, 21-20-3110, 21-22-3516, 21-24-3908, 21-99-0001, 21-TA-3516, 21-20-3112, 21-22-3912, 21-24-3910, 21-99-0002, 21-TA-3908, 21-20-3114, 21-22-3914, 21-24-3912, 21-99-0002-2-1, 21-TA-3910, 21-20-3116, 21-22-3916, 21-24-3914, 21-99-0002-3-1, 21-TA-3912, 21-20-3508, 21-23-2708, 21-24-3916, 21-99-0002-3-2, 21-TA-3914, 21-20-3510, 21-23-2710, 21-25-3112, 21-LT-2708, 21-TA-3916, 21-20-3512, 21-23-2712, 21-25-3114, 21-LT-2710, 21-XT-3112, 21-20-3514, 21-23-2714, 21-25-3116, 21-LT-2712, 21-XT-3114, 21-20-3516, 21-23-2716, 21-25-3512, 21-LT-2714, 21-XT-3116, 21-20-3908, 21-23-3108, 21-25-3514, 21-LT-2716, 21-XT-3512, 21-20-3910, 21-23-3110, 21-25-3516, 21-LT-3108, 21-XT-3514, 21-20-3912, 21-23-3112, 21-25-3912, 21-LT-3110, 21-XT-3516, 21-20-3914, 21-23-3114, 21-25-3914, 21-LT-3112, 21-XT-3912, 21-20-3916, 21-23-3116, 21-25-3916, 21-LT-3114, 21-XT-3914, 21-21-2708, 21-23-3508, 21-40-0100, 21-LT-3116 & 21-XT-3916.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution -- AL, AZ, CA, CT, ID, KS, MO, NH, NV, NY, OH, OK, TX & UT.
  • Descripción del producto
    Vu a-POD Intervertebral Body Fusion Device. Packaged as surgical kits containing all implants and instruments required for a procedure. Also packaged as individual instruments and implants in poly bags distributed as replenishment for surgical kits. Theken Spine, LLC, Akron, OH 44306. || Indicated for use as an adjunct for fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.