Events

Retiro De Equipo (Recall) de REFLEX HYBRID ANTERIOR 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 Stryker Spine.

¿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
    49441
  • Clase de Riesgo del Evento
    Class 3
  • Número del evento
    Z-0217-2009
  • Fecha de inicio del evento
    2008-08-18
  • Fecha de publicación del evento
    2008-11-20
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-06-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73332
  • 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
    The reflex hybrid 4.0 x 14 mm variable, self tapping bone screw, lot nsz, was determined to have been anodized with the incorrect color for that screw.
  • Acción
    An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.

Device

REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
  • Modelo / Serial
    Lot code: NSZ.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution.
  • Descripción del producto
    Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). || Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. || The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Dirección del fabricante
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA