Events

Retiro De Equipo (Recall) de Device Recall Integra NewPort MIS System

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
    68679
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2182-2014
  • Fecha de inicio del evento
    2014-06-27
  • Fecha de publicación del evento
    2014-08-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-09-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128439
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc - Product Code NKB
  • Causa
    Integra lifesciences is recalling the integra newport mis system because there is a possibility that components from the demonstration set may have been mixed with the newport mis pedicle screw system components used in surgery.
  • Acción
    The firm, Integra, sent an "URGENT MEDICAL DEVICE CORRECTION FIELD SAFETY NOTICE" dated June 27, to its customers. The letter informs the customers that Integra Lifesciences is recalling the Integra NewPort MIS System because there is a possibility that the components from the demonstration set may have been mixed with the NewPort MIS pedicle screw system components used in the surgery. The letter also informs the customers of the problems identified and the actions to be taken. Customers are instructed to complete the attached response form and return it by email or fax as indicated on the form. Customers with questions regarding the recall letter instructions are instructed to contact the Marketing Manager at (760) 207-7050.

Device

Device Recall Integra NewPort MIS System
  • Modelo / Serial
    The affected Serial No.'s are: NWP-016 (NewPort Implant Tray w/ Components) NWP2-015 (NewPort Instrument Tray w/ Components)
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution in TX only.
  • Descripción del producto
    Integra NewPort MIS System || Model No. || NWPIMP (NewPort Implant Tray w/ Components) || NWP2INSTP (NewPort Instrument Tray w/ Components) || The NewPort System is intended to be used as a temporary or permanent posterior, non-cervical implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.