Events

Retiro De Equipo (Recall) de Device Recall ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE

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 Sofamor Danek USA 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
    63157
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0036-2013
  • Fecha de inicio del evento
    2012-08-30
  • Fecha de publicación del evento
    2012-10-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-08-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112706
  • 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
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • Causa
    Lines on the screw gauge may not placed on the caddy properly which could result in improper measurement of screws. an incorrect gauge could measure a screw to be approximately 1 mm shorter than its actual length.
  • Acción
    Medtronic conducted a conference call on August 30, 2012 and sent an "URGENT VOLUNTARY RECALL" notice dated September 3, 2012 to all affected customers. The notice identified the product, problem, and actions to be taken by the customers. A Recall Questionnaire Form was attached to the letter for customers to complete and return. Contact your Medtronic Sales representative or the firm's Global Quality Department at 800-876-3133, ext. 3197 for questions regarding this notice.

Device

Device Recall ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE
  • Modelo / Serial
    All lots except those starting with SY
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution-USA (nationwide) and the countries of India, Netherlands, Hong Kong, S. L Korea, Singapore, Canada, Australia, Japan, and Mexico.
  • Descripción del producto
    ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. || Orthopedic. || This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for || single use, this instrument may be re-used.
  • Manufacturer
    Medtronic Sofamor Danek USA Inc

Manufacturer

Medtronic Sofamor Danek USA Inc
  • Dirección del fabricante
    Medtronic Sofamor Danek USA Inc, 1800 Pyramid Place, Memphis TN 38132
  • 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