Events

Retiro De Equipo (Recall) de Device Recall NK Flex Pin Guides

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 Materialise USA LLC.

¿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
    61699
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1544-2012
  • Fecha de inicio del evento
    2012-03-23
  • Fecha de publicación del evento
    2012-05-14
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-01-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108753
  • 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
    March 23, 2012 a field representative reported patient specific --0242 l tibia guide case packaging contained a different patient specific ..-0864-r tibia guide. the two patient specific products had been switched in packaging. neither products had been delivered to the end user.
  • Acción
    Materialise telephoned both field representatives on March 23, 2012 and confirmed recalled product mix-up. Materialise requested both cases be returned and replacements were provided. No affected product was received by the end user.

Device

Device Recall NK Flex Pin Guides
  • Modelo / Serial
    Lot 56529886, REF 005970-000-03 Exp 2012-09-08
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including the states of Ohio and Minnesota.
  • Descripción del producto
    PATIENT SPECIFIC INSTRUMENTS || N-K FLEX PIN GUIDES (FEMUR AND TIBIA) || NONSTERILE ~ MUST BE STERILIZED PRIOR TO USE || Patient ID ..- 0864-R3 Manufactured by Materialise, Plymouth, MI || Distributed by Zimmer, Warsaw IN. || Patient specific instrument is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient image scans.
  • Manufacturer
    Materialise USA LLC

Manufacturer

Materialise USA LLC
  • Dirección del fabricante
    Materialise USA LLC, 44650 Helm Ct, Plymouth MI 48170-6061
  • Empresa matriz del fabricante (2017)
    Materialise Nv
  • Source
    USFDA