Events

Retiro De Equipo (Recall) de EvolisFemoral Sizer Posterior Reference

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 Medacta Usa Inc.

¿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
    55465
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2095-2010
  • Fecha de inicio del evento
    2009-09-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-02-29
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=90927
  • 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/metal/polymer - Product Code JWH
  • Causa
    Medacta usa inc is initiating a recall on the femoral sizer, an orthopedic manual surgical instrument, because the "l" and "r" markings are mislabeled which would cause incorrect usage.
  • Acción
    The firm, Medacta USA Inc, sent an "Urgent Safety Notification" letter dated August 5, 2009, to the customers. The letter describes the product, problem and the action to be taken by the customers. The customers were instructed to check their inventory for devices listed, if found, to immediately sequester them and DO NOT use them in surgery. The customers were ask to please pack the affected femoral sizer(s) posterior reference for shipment to Medacta USA. Medacta informed the customers that Medacta USA personnel will contact them by telephone to provide them with an RMA number and the reworked femoral sizer(s) posterior reference will be returned as soon as they are available. If you have any questions, please feel free to contact the Medacta USA office at 805-437-7085 or contact Ms. Heather Neely directly at 805-886-1069.

Device

EvolisFemoral Sizer Posterior Reference
  • Modelo / Serial
    Model Number: 02.07.10.0215
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: USA including states of Texas and Idaho and country of France.
  • Descripción del producto
    Evolis-Femoral Sizer Posterior Reference || The femoral sizer posterior reference is a manual orthopedic surgical instrument that is used to determine the trial size and set the external rotation. The femoral sizer is an alternate instrument that can be used in addition to the standard MIS femoral sizer. || The Femoral Sizer Posterior Reference intended to be placed on the distal femoral cut and determine the trail size and set the external rotation in preparation for the cut blocks. The femoral sizer posterior reference is intended to be placed on the distal femoral cut and determine the trial size and set the external rotation in preparation for the cut blocks. Indications for Use for the Medacta Evolis Total Knee System are: The Evolis Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components. This knee replacement system is indicated in the following cases: - Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis - Avascular necrosis of femoral condyle - Post traumatic loss of joint configuration - Primary implantation failure.
  • Manufacturer
    Medacta Usa Inc

Manufacturer

Medacta Usa Inc
  • Dirección del fabricante
    Medacta Usa Inc, 4725 Calle Quetzal Unit B, Camarillo CA 93012-9101
  • Empresa matriz del fabricante (2017)
    Medacta Holding Sa
  • Source
    USFDA