Events

Retiro De Equipo (Recall) de Novation Element

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 Exactech, 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
    72357
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0201-2016
  • Fecha de publicación del evento
    2015-11-02
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-03-01
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140738
  • 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, uncemented, metal/polymer, non-porous, calicum-phosphate - Product Code MEH
  • Causa
    Eight (8) pieces did not receive the specified hydroxyapatite (ha) coating.
  • Acción
    The firm, Exactech, issued an "IMPORTANT NOTIFICATION-PRODUCT RECALL ADVISORY NOTICE" dated September 23, 2015, by phone and by mail to their consignees. The notice described the product, problem and actions taken. The consignees were instructed to 1) Immediately cease distribution or use of these products. 2) Extend this information to your accounts that may have this product in their possession. 3) Identify and quarantine any of the subject Novation Element Pres Fit Femoral stem in your inventory. 4) Complete and Return the attached Recall Inventory Response Form to Exactech,per the instructions provided on the notice itself, within 5 business days, via fax to: 352-337-3915 or email kaya@exac.com. Return products to: Exactech Distribution Center, 2411 NW 66th Court, Gainesville, Florida 32653, Attention: Exactech inventory representative. Any questions contact your Exactech inventory representative at kaya@exac.com or 1-800-392-2832.

Device

Novation Element
  • Modelo / Serial
    Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to states of: AZ, CO, FL, and MD.
  • Descripción del producto
    Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Dirección del fabricante
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Empresa matriz del fabricante (2017)
    Exactech Inc
  • Source
    USFDA