Retiro De Equipo (Recall) de Integra Ruggles Surgical Instrument ACF Distraction Screws

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • 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
    A packaging error had occurred where 16 mm screws were packaged and labeled as 12 mm screws and vice versa.
  • Acción
    Urgent: Product Recall Notification letters were sent via Fed Ex on October 22, 2008. The letter asked customers to quarantine any of the affected stock on hand and contact their local Integra Sales Representative for further assistance and for arrangement of product returns. Customers were to fill out the attached "Recall Acknowledgement and Return Form" indicating whether or not they possess any of the product identified in the letter. Additional questions can be directed to Christin Roach at 609-936-5413. A Urgent: Product Recall Second Notification dated 1/5/2009 was sent to customers providing them with additional information on the packaging error and included immediate and/or product used during surgery. This notification also requested that all surgeons be notified who were or may have been provided with any of the screws affected by this recall.


  • Modelo / Serial
    lot code 326081; and lot code 327081.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Integra Ruggles Surgical Instrument ACF Distraction Screws || Sterile, Rx only || Catalog number R6357A (12 mm), Catalog number R6397A (16 mm), || Integra LifeSciences Corp., 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer