Events

Retiro De Equipo (Recall) de Device Recall Integra External Fixation System Rocker Bottom Model 12225400

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
    74583
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2296-2016
  • Fecha de inicio del evento
    2016-07-01
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147962
  • 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
    Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
  • Causa
    The silicone insert embedded in the rocker bottom has the potential to become dislodged or loose from the rocker bottom mold.
  • Acción
    All affected consignees were notified via an "Urgent: Voluntary Medical Device Recall" letter sent on 7/1/16. The letter identified the affected product as well as the reason for the recall. Customers were asked to check their traceability records for shipments of the affected product. If the affected parts are found, customers are to stop use and distribution. A copy of the letter should be provided to any customers that the product may have been distributed to. The attached "Acknowledgement and Return Form" should be completed and returned regardless if customers have affected product or not. Questions regarding the instructions should be directed to Customer Service at 1-800-654-2873.

Device

Device Recall Integra External Fixation System Rocker Bottom Model 12225400
  • Modelo / Serial
    Lot # PN625.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Distributed in the US to the states of FL, VA, OK, CO, DC, and IN.
  • Descripción del producto
    Integra External Fixation System Rocker Bottom Model # 12225400. || For use in the treatment of bone conditions amenable to treatment by the use of external fixation.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.