Events

Retiro De Equipo (Recall) de Device Recall SPINE BUTTRESS (FANG) 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 Spinal Solutions, LLC.

¿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
    64586
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1418-2013
  • Fecha de inicio del evento
    2013-02-20
  • Fecha de publicación del evento
    2013-05-27
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-03-26
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118191
  • 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 recall of the loaner bin and sterilization trays for implants and instruments was initiated by spinal solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
  • Acción
    Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

Device

Device Recall SPINE BUTTRESS (FANG) PLATE SYSTEM
  • Modelo / Serial
    Item # FP1220 FP1221
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
  • Descripción del producto
    Fang Screw 20mm || Fang Plate 21mm || Product Usage: || Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
  • Manufacturer
    Spinal Solutions, LLC

Manufacturer

Spinal Solutions, LLC
  • Dirección del fabricante
    Spinal Solutions, LLC, 26157 Jefferson Ave, Murrieta CA 92562-9561
  • Source
    USFDA