Events

Retiro De Equipo (Recall) de Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate 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 Captiva Spine, 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
    61811
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1649-2012
  • Fecha de inicio del evento
    2011-11-22
  • Fecha de publicación del evento
    2012-05-23
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-11-18
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109149
  • 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
    Captiva spine is recalling the smartlox cervical plate components 12 & 14 mm drill bits, single barrel variable drill guides, and double barrel fixed drill guides. the components are part of the instrumentation kit used to complete an anterior screw fixation of the cervical spine. there is a potential risk for the drills to not properly fit through the drill guides due to an overlap in the dime.
  • Acción
    Captiva Spine notified customers of the recall by letter on November 23, 2011, and advised that the affected products would be replaced. Customers were asked to return the drill guides and unused drills with the provided return labels. For questions customers should call 877-772-5571. For questions regarding this recall call 561-277-9480.

Device

Device Recall Accessories for the Captiva Spine SmartLOX Cervical Plate System.
  • Modelo / Serial
    Lot Numbers: 1500705A, 06110041, 1500707A, 06110043, 1500708A, and 06110044
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including TX, IN, UT, AZ, GA, CA, AL, MI, and MN.
  • Descripción del producto
    Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part: || "***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number 06110041***" || "***Part Number CP50160***Single Barrel Fixed Drill Guide***Lot Number 1500707A or Lot Number 06110043***" || "***Part Number CP50170***Double Barrel Fixed Drill Guide***Lot Number 1500708A or Lot Number 06110044***" || Products are packaged individually and shipped as replacement parts to be placed in the SmartLOX Cervical Plate System tray. || The Captiva Spine SmartLOX Cervical Plate System is intended for the anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion.
  • Manufacturer
    Captiva Spine, Inc

Manufacturer

Captiva Spine, Inc
  • Dirección del fabricante
    Captiva Spine, Inc, 967 Alternate A1A, Suite1, Jupiter FL 33477
  • Empresa matriz del fabricante (2017)
    Captiva Spine Inc.
  • Source
    USFDA