Retiro De Equipo (Recall) de Device Recall XGuide Surgical Navigation 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 X-NAV Technologies, LLC.

¿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
    73544
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1391-2016
  • Fecha de inicio del evento
    2016-02-23
  • Estado del evento
    Terminated
  • País del evento
  • Fecha de finalización del evento
    2016-11-01
  • 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
    Dental stereotaxic instrument - Product Code PLV
  • Causa
    The x-guide system utilizes an x-clip (pn p007665) which contains fiducials to assist with registration of the patient anatomy. the x-clip is a device worn intraorally by a patient during the ct scan and guided surgery procedures. the x-clip contains three fiducial markers made from a stainless steel material. the x-nav specification requires these fiducials be fabricated from stainless steel 3.
  • Acción
    The firm, X-Nav Technologies, LLC, sent a "Medical Device Recall" letter date 2/23/2016 via mail and email to customers indicating the issue and risks involved. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory of X-Clips and remove any product containing the affected lots; complete the enclosed Acknowledgement and Receipt form to record the lot numbers located on the labeling for parts and discard affected product and return form to firm by Email to: Vigilance@X-Navtech.com or by Mail to: X-NAV TECHNOLOGIES, LLC, 1555 BUSTARD ROAD, SUITE 75,LANSDALE, PA. 19446, ATTN: Director, Quality Assurance and Regulatory Affairs, even if you have already used or no longer have possession of the X-Clips identified. Should you have any questions regarding this notification, please contact our Customer Service representatives at 267.436.0420 from 8:30a.m. to 5:30p.m. (EST) Monday-Friday.

Device

  • Modelo / Serial
    Model Numbers: P007665 X-Clip; Component of System P007839. Note: P007665 X-Clip Component is distributed as X-Clip Bulk Kit PN P008381, package of 12 pieces P007665.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Distribution to: FL, OR, NE, PA, NM, FL, VA, OH, WA, CA, MD, LA, ID, CN, TN, and DC.
  • Descripción del producto
    X-Guide Surgical Navigation System, X-Clip Bulk Kit || The X-Guide Surgical Navigation System is a computerized navigational system intended to provide assistance in both the preoperative planning phase and the intra-operative surgical phase of dental implantation procedures.
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    X-NAV Technologies, LLC, 1555 Bustard Rd Ste 75, Lansdale PA 19446-5731
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA