Events

Retiro De Equipo (Recall) de 3DKnee e Tibial Insert

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 Encore Medical, Lp.

¿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
    62801
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2302-2012
  • Fecha de inicio del evento
    2012-08-09
  • Fecha de publicación del evento
    2012-08-30
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111744
  • 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
    Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer + additive/metal/polymer - Product Code OIY
  • Causa
    The firm is recalling one lot of 392-09-706, 3dknee e+ tibial insert, 9 mm, size 6, right. the shelf life labeling of specific lots for a component were found to be incorrect and were found to be expired.
  • Acción
    DJO Global sent an Urgent Field Safety Notice dated August 9, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to forward the Notice to all those who need to be aware within their organization or to any organization where the potentially affected product has been transferred. Customers were instructed to contact the firm to place a replacement order and receive an RMA number. For questions customers were asked to call 512-834-6255. For questions regarding this recall call 512-832-9500.

Device

3DKnee e Tibial Insert
  • Modelo / Serial
    Model Number 392-09-706, Lot Number 59602519
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution including Venezuela.
  • Descripción del producto
    3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm. || The insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along lateral condyle. This insert is to be used along with the other components that comprise the 3DKnee System.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

Encore Medical, Lp
  • Dirección del fabricante
    Encore Medical, Lp, 9800 Metric Blvd, Austin TX 78758
  • Source
    USFDA