Events

Retiro De Equipo (Recall) de Foundation NonPorous Hip 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 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
    59739
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0418-2012
  • Fecha de inicio del evento
    2011-08-17
  • Fecha de publicación del evento
    2012-01-11
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-05-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=103532
  • 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, hip, semi-constrained, metal/polymer, - Product Code JDI
  • Causa
    The sterility has the potential to be compromised.
  • Acción
    Encore Medical Lp sent a Urgent Field Safety Notice dated August 17, 2011. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to immediately quarantine these devices if you have not already done so. Contact Customer Service to obtain replacement devices as well as an RMA. Return all affected devices by October 31, 2011, using the RMA Customer Service provided in step #3. If you have any further questions you may call (512 ) 834-6330. For International Customer Service please call (512) 834-6275.

Device

Foundation NonPorous Hip System
  • Modelo / Serial
    All devices packaged prior to July 1, 2008. Model/Catalog Number: 460-01-090, 460-01-105, 460-01-120, 460-01-135, 460-01-150, 460-01-165
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution -- USA ( nationwide ) including the states of WI, NY, MO, TX, FL, CA, UT, AZ, Puerto Rico, and the country Japan.
  • Descripción del producto
    FOUNDATION HIP SYSTEM Series 460 Hip Stem STERILE R CEMENTED Sz 16.5mm || DJO Surgical 9800 Metric Blvd., Austin, TX 78758 || The Foundation Non-Porous Stem is intended for treatment of patients who are candidates for total or hemi-hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or femoral neck fracture, and revision arthroplasty where bone loss is minimal. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion and are intended to be used with bone cement.
  • Manufacturer
    Encore Medical, Lp

Manufacturer

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