Events

Retiro De Equipo (Recall) de Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25

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 Vilex In Tennessee 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
    71344
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1722-2015
  • Fecha de inicio del evento
    2015-04-22
  • Fecha de publicación del evento
    2015-06-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-10-30
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137354
  • 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
    Rod, fixation, intramedullary and accessories - Product Code HSB
  • Causa
    Incidence of breakage is higher than expected.
  • Acción
    The initial telephone call (4/9/2015) informed the distributor that the product was on hold (not to be used or transferred). The second telephone call (4/29/2015) and letter informed the customer that the product was being removed from market and that the customer was to return the product to the corporate office. The letter was disseminated on 05/05/2015 to distributors via certified mail. The letter contains the instructions for them to follow, which as summarized are: inventory all products on hand, sign off on inventory sheet, send products back to the corporate office with the identified return number on the shipping container, inform the corporate office that the process has been completed and provide the corporate office with the list of the products returned. A second letter was disseminated to sales representatives (distributors), surgeons, and hospitals on 05/28/2015.

Device

Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25
  • Modelo / Serial
    all codes
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the states of MS, MD, PA, and TX.
  • Descripción del producto
    Vilex, Inc., FUZE 10.0 mm x 200 mm, Product # FZ100-200T-25. || Ankle arthrodesis, tibio-talo-calcaneal arthrodesis.
  • Manufacturer
    Vilex In Tennessee Inc

Manufacturer

Vilex In Tennessee Inc
  • Dirección del fabricante
    Vilex In Tennessee Inc, 111 Moffitt Street, Mcminnville TN 37110-2235
  • Empresa matriz del fabricante (2017)
    Vilex In Tennessee Inc.
  • Source
    USFDA