Events

Retiro De Equipo (Recall) de Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer 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 Medtronic Spine LLC (formerly 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
    58425
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-3175-2011
  • Fecha de inicio del evento
    2011-03-23
  • Fecha de publicación del evento
    2011-09-09
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-09-09
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99328
  • 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
    Arthroscope - Product Code HRX
  • Causa
    Device was shipped past the labeled expiration date.
  • Acción
    On 3/23/2011, the firm initiated the recall and sent Urgent Notice: Device Recall letters identifying the affected product and explaining the reason for the recall. The letter asks customers not to use the affected product with the lot number 0001653390. The firm will replace any affected product at no cost to the customer. A Medtronic Spine Sales representative will assist with the segregation and return of the affected product. They will also assist the customer with contacting Medtronic Spine Customer Service to return the affected product. Included with the letter was a reconciliation form with instructions regarding the affected product. Questions regarding the letter should be directed to Customer Service at 866-959-7466.

Device

Device Recall KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System
  • Modelo / Serial
    Lot Number: 0001653390
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Nationwide Distribution
  • Descripción del producto
    Kyphon brand KyphoPak Express Tray First Fracture, 15/2 with KyphX Osteo Introducer System; Catalog Number: KPE1003; Product is manufactured and distributed by Medtronic Spine LLC (formerly known as Kyphon Inc), Sunnyvale, CA || Designed to reduce kyphosis that results from vertebral body collapse due to osteoporosis.
  • Manufacturer
    Medtronic Spine LLC (formerly Kyphon Inc.)

Manufacturer

Medtronic Spine LLC (formerly Kyphon Inc.)
  • Dirección del fabricante
    Medtronic Spine LLC (formerly Kyphon Inc.), 1221 Crossman Ave, Sunnyvale CA 94089-1103
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA