Events

Retiro De Equipo (Recall) de Device Recall Apex Knee 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 OMNIlife science 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
    79268
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1117-2018
  • Fecha de inicio del evento
    2017-11-20
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161796
  • 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
    The apex knee system tibial baseplate identified has an improper expiration date marked on the external packaging. the improper expiration date (2202-03) is marked on the external packaging only. the correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
  • Acción
    OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017. Actions to be taken by the Customer/User "Immediately quarantine lot 26519 for KC-2206L "Return Product Using RMA# XXXX to OMNI. "This advisory notice only includes LOT 26519. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to CS@omnils.com. For further questions, please call (508) 824-2444.

Device

Device Recall Apex Knee System
  • Modelo / Serial
    Product Code KC-2206L, Lot # 26519
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Distribution and to the country Spain.
  • Descripción del producto
    Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L || The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
  • Manufacturer
    OMNIlife science Inc.

Manufacturer

OMNIlife science Inc.
  • Dirección del fabricante
    OMNIlife science Inc., 480 Paramount Dr, Raynham MA 02767-1085
  • Empresa matriz del fabricante (2017)
    Omnilife Science Inc
  • Source
    USFDA