Events

Retiro De Equipo (Recall) de KyphX Xpander

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 Kyphon 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
    27597
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0147-04
  • Fecha de inicio del evento
    2003-10-13
  • Fecha de publicación del evento
    2004-07-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2004-03-08
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=30158
  • 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
    Injector And Syringe, Angiographic - Product Code DXT
  • Causa
    Devices for which sterility may be compromised as evidenced by a loss of package integrity.
  • Acción
    On October 13, 2003, all consignees were notified via letter and on-site visit by a Kyphon sales representative, informing them of the affected devices and providing instructions on the recall.

Device

KyphX Xpander
  • Modelo / Serial
    Kyphon (KyphoPak Tray) Introducer Tool kit: Catalog No. KPT1001 with Lot No. 03090901, Catalog No. KPT1002 with Lot No. 03090902, Catalog No. KPT1003 with Lot No. 03090903, Catalog No. KPT1501 with Lot No. 03091704, Catalog No. KTP1503 with Lot No. 03091705, Catalog No. KPT2002 with Lot No. 03090807, Catalog No. KPT2003 with Lot No. 03090806
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    There were a total of 188 direct customers that received the recalled product distributed by Kyphon. There were 0 (zero) wholesaler dealers, distributors, retailers that received the recalled product distributed by Kyphon. The recalled product was distributed in the United States only. Recalled product was distributed by Kyphon to one VA hospital, VA Medical Center of San Diego, 3350 La Jolla Village Dr. San Diego, CA 92161. There were no shipments to foreign or Canadian distribution.
  • Descripción del producto
    KyphXR brand KyphoPak Tray, a Introducer Tool kit for Inflation Syringe || Kyphon Catalog Number: KPT1001, KPT1002, KPT1003, KPT1501, KPT1503, || KPT2002, KPT2003 || The medical device is distributed by Kyphon under the brand name KyphX Xpander Inflation Syringe. This medical device is provided as an individual stand-alone package (which also contains an accessory locking syringe device) and as an individually packaged component of the KyphoPak Tray. The Inflation Syringe packaging and contents are identical whether provided as a stand-alone package or as a component of the KyphoPak Tray.
  • Manufacturer
    Kyphon Inc

Manufacturer

Kyphon Inc
  • Dirección del fabricante
    Kyphon Inc, 1350 Bordeaux Dr, Sunnyvale CA 94089-1005
  • Source
    USFDA