Events

Retiro De Equipo (Recall) de ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm)

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 Wright Medical Technology 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
    53538
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0493-2010
  • Fecha de inicio del evento
    2009-09-22
  • Fecha de publicación del evento
    2009-12-08
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2010-12-16
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85740
  • 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
    Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis - Product Code MBH
  • Causa
    Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. the absence of alloying elements results in an area with less strength. for those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
  • Acción
    Wright Medical initiated the recall of the product on September 22, 2009 by contacting the distributors by telephone followed with letters addressed to the hospitals and surgeons dated October 9, 2009. At the firm, Customer Service is the contact for return instructions and replacement inventory. This phone number is 800-238-7117. Other questions regarding this matter are directed to 800-874-5630.

Device

ADVANCE (R) CANAL FILLING STEM EXTENSION (13mm)
  • Modelo / Serial
    Lot number: 098705612
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, and Greece
  • Descripción del producto
    ADVANCE (R) CANAL FILLING STEM EXTENSION, REF: KSP1-2140, DIAMETER 13mm, LENGTH 140mm, 1 EACH, STERILE R, (FOR USE WITH CEMENT ONLY), SINGLE USE ONLY, (Ti6A14V), Wright Medical Technology, Inc., 5677 Airline Road, Arlington, TN 38002
  • Manufacturer
    Wright Medical Technology Inc

Manufacturer

Wright Medical Technology Inc
  • Dirección del fabricante
    Wright Medical Technology Inc, 5677 Airline Rd, Arlington TN 38002
  • Empresa matriz del fabricante (2017)
    Wright Medical Group NV
  • Source
    USFDA