Events

Retiro De Equipo (Recall) de Device Recall Integra Radionics

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 Integra LifeSciences Corp..

¿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
    57818
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1400-2011
  • Fecha de inicio del evento
    2011-01-12
  • Fecha de publicación del evento
    2011-02-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-04-04
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=97501
  • 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
    Neurological, sterotaxis instrument - Product Code HAW
  • Causa
    Overall length of the intubation hoop in the hraim intubation head ring assembly is too long and will not allow a device to to attach.
  • Acción
    Integra sent a Medical Device Field Corrective Action letter dated January 12, 2011, to all affected customers via Federal Express. Integra Sales Specialists were provided with the replacement part and written instructions on how to replace the affected intubation hoops from customer inventory identified in the traceability report. Upon completion of the field correction each sales specialist was instructed to return the affected hoop along with a completed copy the Recall Acknowledgement and Return Form. If additional information is required contact me at (609) 936-2485 or james.tillman@integraJife.com.

Device

Device Recall Integra Radionics
  • Modelo / Serial
    Lot/Serial Number(s): 0189463, 0189289, 0186642, 0184885
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - USA, Canada, and Australia
  • Descripción del producto
    Integra Radionics HRAIM Intubation Head Ring Assembly || Ref: HRAIM Head Rings serve as the general stereotactic treatment platform. Head Rings are used to provide a reference frame for instrumentation used for precise spatial localization and treatment of physiologic targets for stereotactic neurosurgical procedures such as craniotomies, biopsies, functional neurosurgery, and radiation therapy. Head Rings are delivered to the user non-sterile, and are reusable.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.