Retiro De Equipo (Recall) de Device Recall InterFuse Tail Traction Tool

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 Vertebral Technologies, 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
    76275
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1151-2017
  • Fecha de inicio del evento
    2017-01-13
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2017-10-05
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Causa
    Fit issues have been identified with the tail traction tool (pn 9116) when used with the interfuse t tailed implant. the interfuse t tail may not fit into the thru hole in the instrument.
  • Acción
    Consignees were sent via email a VTI "Advisory Notice" letter. The letter listed the Concern, Impact, Alternate Methods, Affected Lots, and Your Responsibility. Consignees were requested to acknowledge receipt of this notice, Discontinue use of the Tail Traction Tool when implanting the InterFuse T tailed implant, Notify individuals that may potentially use the device and alternate module assembly methods. Advise consignees to contact Customer Service (1-877-912-5401 in US , +-952-912-5400 outside US or customerservice@vti-spine.com to obtain a replacement instrument.

Device

  • Modelo / Serial
    Lot: 110512-02, 110718-01, 110831-02, 120214-01, 120403-018, 120420-07, 120711-02, 120911-06
  • Clasificación del producto
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US: IL, WI, OH, NY, MT, FL, MD, IN, TN, TX, MN. OUS: Italy, Taiwan Spain, Belgium, Canada, Netherlands, Sweden, Switzerland, Portugal, Brazil. Germany, Ireland,
  • Descripción del producto
    InterFuse Tail Traction Tool, Part Number 9116. || The InterFuse Tail Traction Tool is an optional Class I non-sterile reusable instrument that can be used to assist with module locking of the InterFuse S or InterFuse T implant system. || The system has a modular design to allow the device to be assembled within the disc space to minimize the surgical window, while providing a footprint that approximates the excised nucleus.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    Vertebral Technologies, Inc., 13845 Industrial Park Blvd, Minneapolis MN 55441-3746
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA