Events

Retiro De Equipo (Recall) de Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments

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 Limited.

¿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
    62464
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2028-2012
  • Fecha de inicio del evento
    2012-05-23
  • Fecha de publicación del evento
    2012-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-03-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110714
  • 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
    Coagulator-cutter, endoscopic, unipolar (and accessories) - Product Code KNF
  • Causa
    The integra(tm) jarit(r) take-apart laparoscopic instrument shafts were released with internal component out of specification.
  • Acción
    Integra sent a Urgent Field Corrective Action letter dated May 23, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed customers and sales reps to return the instruments identified on the attached part number list and complete a "Field Corrective Action Acknowledgement and Return Form" to be completed and returned to the firm. We apologize for any inconvenience this issue may cause you. Please call Integra Surgical Customer Service at 800-431-1123 if you have any questions.

Device

Device Recall Integra(TM) Jarit(R) TakeApart Endoscopic Instruments
  • Modelo / Serial
    Model number 643350 -- batch numbers 1045878, 1045879, 1045881, 1045880, 1045872, 1045882, 1045876, 1045877, 1045873, 1045874, and 1045875. Model number 643425 -- batch numbers 1045890, 1045886, 1045884, 1045887, 1045888, 1045889, and 1045885. Model number 643650 -- batch numbers 1045891, 1045892, and 1045893. Model number 643725 -- batch numbers 1045894 and 1045895.
  • Clasificación del producto
    Obstetrical and Gynecological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    USA (nationwide) including the states of AZ, CA, IL, MA, MN, NJ, OK, TN, TX, VA, WA and WI.
  • Descripción del producto
    Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. || Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument for grasping, dissecting and/or other manipulation of soft tissue is determined to be appropriate by the surgeon.
  • Manufacturer
    Integra Limited

Manufacturer

Integra Limited
  • Dirección del fabricante
    Integra Limited, 311 Enterprise Dr, Plainsboro NJ 08536-3344
  • Source
    USFDA