Events

Retiro De Equipo (Recall) de Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.

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 X Spine Systems 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
    71357
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1823-2015
  • Fecha de inicio del evento
    2015-04-07
  • Fecha de publicación del evento
    2015-06-22
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-10-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137421
  • 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, spondylolisthesis spinal fixation - Product Code MNH
  • Causa
    The continuous radius rod should measure 50mm in length but actually measures 45mm in length.
  • Acción
    X-Spine sent an Urgent Medical Device Recall Letter dated April 13, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: 1. The affected hospital and surgeon should be notified of this recall immediately. 2. Complete the attached Medical Device Recall Return Response Form and return it with any affected product in inventory to X-Spine Systems immediately. a. Reference RMA # 5410 b. Use enclosed shipping label 3. No action should be taken with product that has been implanted. Please feel free to contact me at 800.903.0640 ext. 137.

Device

Fortex Pedicle Screw System Continuous Radius Rod 5.5 50mm, XSpine Systems, Inc.
  • Modelo / Serial
    Model #: N60001068; Lot #: 2943-01; Serial #s: 46118, 46581, 47296, 47588, 47653, 48164, 48201, 48412, 49156, 49585, 49586, 49649, G22, G45, G47, G77, G83, G87X, G90X, R15, XP03, XP21, XP27, XP28, XP29 & XP32.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution to the states of : FL, ID, IL, KS, LA, MI, MO, NJ, OH, PA and TX., and to the countries of Austria, Germany and Italy.
  • Descripción del producto
    Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
  • Manufacturer
    X Spine Systems Inc

Manufacturer

X Spine Systems Inc
  • Dirección del fabricante
    X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
  • Empresa matriz del fabricante (2017)
    X-Spine Systems, Inc
  • Source
    USFDA