Events

Retiro De Equipo (Recall) de SpFXL IIB 2/DM Implantable Stimulator

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 EBI Patient Care, 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
    77089
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2118-2017
  • Fecha de inicio del evento
    2017-04-20
  • Estado del evento
    Completed
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154946
  • 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
    Stimulator, invasive bone growth - Product Code LOE
  • Causa
    Zimmer biomet is conducting a medical device field action for the spf plus-mini and spf xl iib implantable spinal fusion stimulator products due to higher than allowed cytotoxicity levels found during routine process monitoring with the product.
  • Acción
    An Urgent Medical Device Recall letter, dated April 20, 2017, was sent to the firm's consignees. The letter identified the affected product and the reason for the recall, as well as the risks involved. Consignees were instructed to quarantine affected product in their inventory and complete the Certification of Acknowledgement portion and the Inventory Return Certification Form in the letter. Affected product must be returned immediately along with the completed Inventory Return Certification Form. Questions or concerns should be directed to the customer call center at 1-800-447-3625 or via email to corporatequality.postmarket@zimmerbiomet.com.

Device

SpFXL IIB 2/DM Implantable Stimulator
  • Modelo / Serial
    Serial Numbers: 224595 224598 224607 224608 224610 224613 224615 224621 224622 224623 224624 224625 224626 224644 224649 224651 224655 224656 224658 224659 224666, and  224667.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    No
  • Distribución
    Nationwide distribution only.
  • Descripción del producto
    10-1335M - SpF-XL IIB 2/DM Implantable Stimulator. || Indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels.
  • Manufacturer
    EBI Patient Care, Inc.

Manufacturer

EBI Patient Care, Inc.
  • Dirección del fabricante
    EBI Patient Care, Inc., 484 Calle E, Guaynabo PR 00969-3454
  • Source
    USFDA