Events

Retiro De Equipo (Recall) de Firebird NXG Spinal Fixation System Decorticating Planer

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
    77882
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3127-2017
  • Fecha de inicio del evento
    2017-08-02
  • Fecha de publicación del evento
    2017-08-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-05-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158127
  • 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
    Thoracolumbosacral pedicle screw system - Product Code NKB
  • Causa
    The plastic core of the decorticating planer was found to be missing, which could result in scoring of the bone screw neck if used at or beyond a 23 degree angle.
  • Acción
    Orthofix sent an Urgent Medical Device Product Recall letter dated August 2, 2017, to all affected customers. The letter explained the issue and requested return of product in their possession. Customers with questions were instructed to contact their local Orthofix representative. For questions regarding this recall call 214-937-2100.

Device

Firebird NXG Spinal Fixation System Decorticating Planer
  • Modelo / Serial
    Lot #203013-TD26
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distribution was made to distributors located in CA, FL, and RI. There was no foreign/military/government distribution.
  • Descripción del producto
    Firebird NXG Spinal Fixation System Decorticating Planer, Catalog #36-1334, non-sterile, Rx. || .A Decorticating Planer is used to decorticate bone surrounding the spherical head of an implanted bone screw in order to provide clearance to allow for proper seating of the modular body, as well as to provide full range of modular body angulation. It is placed axially over the spherical head of the bone screw and rotated clockwise and counterclockwise to achieve the needed decortication
  • 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