Events

Retiro De Equipo (Recall) de GDC18 360 20mm x 33cm

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 Neurovascular.

¿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
    69669
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0480-2015
  • Fecha de inicio del evento
    2014-10-22
  • Fecha de publicación del evento
    2014-12-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2015-02-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131300
  • 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
    Device, neurovascular embolization - Product Code HCG
  • Causa
    Units of gdc 360 coils, target coil and gateway pta balloon catheter were shipped to us customers beyond the expiration date.
  • Acción
    Stryker Neurovascular sent an Urgent Medical Device Recall Notification dated October 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Letters request that users take the following actions: 1. Immediately locate the subject devices and quarantine them. 2. Distribute this notice to all affected Departments in your facility. 3. Inform Stryker Neurovascular if any of the subject devices have been distributed to other organizations. a. Please provide contact details so that Stryker Neurovascular can inform those recipients appropriately. 4. Complete and sign the attached Customer Response Form and: a. Fax it to: 1-866-876-4355 or b. E-mail a copy to: NeuroComplaints@stryker.com c. Please complete this form even if you do not have any subject devices to return to prevent the need of follow up notices. 5. Keep a copy of the completed, signed Customer Response Form for your records. Stryker Customer Service reps will contact customers to arrange for replacement. Any returned product will be quarantined and destroyed.

Device

GDC18 360 20mm x 33cm
  • Modelo / Serial
    Model M00334820330, Lot number: 12881100; Exp. Jul 2012.
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    US Distribution to the states of: VA, NH, OH and TX.
  • Descripción del producto
    GDC-18 360 20mm x 33cm ; || GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's || general medical condition - are considered by the treating neurosurgical team to be || a) very high risk for management by traditional operative techniques, or b) inoperable
  • Manufacturer
    Stryker Neurovascular

Manufacturer

Stryker Neurovascular
  • Dirección del fabricante
    Stryker Neurovascular, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    USFDA