Events

Retiro De Equipo (Recall) de CPlus

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 RTI Surgical, 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
    67093
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0627-2014
  • Fecha de inicio del evento
    2013-10-07
  • Fecha de publicación del evento
    2014-01-03
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-02-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124694
  • 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
    Intervertebral fusion device with bone graft, cervical - Product Code ODP
  • Causa
    As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm webless c-plus implants were incorrectly documented as meeting the requirement for labeling as a partial vertebral body replacement device (vbr). while the use of this device as a partial vbr is unlikely due to the size of the device, use of this device as a partial vbr could result in a s.
  • Acción
    RTI Surgical, Inc. sent an Important Notice letter dated October 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed remove fall affected product from their inventory and send back to Customers Service at 375 River Park Circle, Marquette, MI 49855 by October 16, 2013. Customers with questions were instructed to call 906-226-4489. For questions regarding this recall call 906-226-4812.

Device

CPlus
  • Modelo / Serial
    part numbers: 30-CW-1012-5, 30-CW-1012-6, 30-CW-1012-7, 30-CW-1012-8, 30-CW-1012-9, 30-CW-1 012-10, 30-CW-1 012-11.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution - USA including FL, MO, NY, CA, MI,and IL.
  • Descripción del producto
    C-Plus" 10mm x 12mm Webless implants || Pioneer Surgical's C-Plus " 10mm x 12mm Webless implants are cervical intervertebral fusion devices that are intended to stabilize a cervical spinal segment to promote fusion in order to restrict motion and decrease pain. They are intended for use with supplemental fixation and autograft. These implants are manufactured from PEEK (Polyaryletheretherketone) polymer with tantalum marker pins for radiographic visualization.
  • Manufacturer
    RTI Surgical, Inc.

Manufacturer

RTI Surgical, Inc.
  • Dirección del fabricante
    RTI Surgical, Inc., 375 River Park Cir, Marquette MI 49855-1781
  • Empresa matriz del fabricante (2017)
    RTI Surgical Inc
  • Source
    USFDA