Events

Retiro De Equipo (Recall) de Device Recall EGR (Endoscopic Gastrocnemius Release 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 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
    61183
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1226-2012
  • Fecha de inicio del evento
    2012-01-06
  • Fecha de publicación del evento
    2012-03-19
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107479
  • 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
    Accessories,arthroscopic - Product Code NBH
  • Causa
    The firm received several complaints from customers reporting that the blade of the egr system may not retract back into the device following surgery. the firm attributes this problem to user error or improper surgical technique on the part of the physician.
  • Acción
    The firm sent a 'A Medical Device Correction Notice' with an attached Acknowledgement and Return Form to all consignees on 1/6/2012 via FedEx and E-mail. The Correction Notice informs customers of the firm's receipt of several complaints regarding the Endoscopic Gastrocnemius Release (EGR) System and the problem with non-retraction of the blade back into the device during surgery. Although no adverse health consequences or patient injuries have been reported to date, the notice is being issued by the firm in order to reinforce the importance of following the additional clarification to the Surgical Technique Manual. According to the firm, this action should serve to reduce the possibility in which the blade may fail to retract into the device. Questions were directed to (609) 936-6832.

Device

Device Recall EGR (Endoscopic Gastrocnemius Release System
  • Modelo / Serial
    Model # EGR 157, Part No.31-0040 and Model #EGR 138, Part No. 31-0138.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution, including the states of: MI, CA, TX, VT, OK, OH, NC, MN, CT, CO, TN, NY, NJ, MO, FL, WA, AR, MT, VA, IL, PA, NE, GA, AZ, WI, OR, MD, LA, IA, AL, MA, ID, KY, UT, NV, IN and SC.
  • Descripción del producto
    Integra Endoscopic Gastrocnemius Release (EGR) System. The device consists of one (1) unit which is kitted within an instrumentation tray. The Integra EGR System includes a range of instruments for endoscopic approach to the Gastrocnemius Aponeurosis Recession. The cutting instrument features a retracting blade for cutting the gastrocnemius aponeurosis. Associated instruments include an elevator, a cannula, and a cannula obturator, which are all consumable instruments provided sterile. The EGR System is indicated for the treatment of posterior heel cord contracture (Equinus) in those patients who fail to respond to conservative management.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.