Events

Retiro De Equipo (Recall) de Device Recall ENDURAMESH CORPECTOMY SPACER 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 Lucero Medical 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
    60972
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1059-2012
  • Fecha de inicio del evento
    2012-01-11
  • Fecha de publicación del evento
    2012-02-17
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-11
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106929
  • 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
    Spinal vertebral body replacement device - Product Code MQP
  • Causa
    During an fda inspection the firm was informed that the device marketed is not the device cleared for the 510k associated with the device. the product is sold unlabeled.
  • Acción
    Lucero Medical LLC made a personal visit to facilities in regards to an Urgent Medical Device Recall as of January 12, 2012. The firm instructed the customer that they were removing and quarantining all product from the facility. If you have any further questions, please contact Lucero Medical, PO Box 69, Richfield, Ohio 44826, Director of Quality Assurance/Natalie Williams/ (440) 670-9583

Device

Device Recall ENDURAMESH CORPECTOMY SPACER SYSTEM
  • Modelo / Serial
    Part # 762.010, Lot # 110738; Part # 762.019, Lot # 90611, Lot #, 100308; Part # 762.021, Lot # 100308, Lot #, 110106; Part # 762.023, Lot # 90611, Lot # 100218, Lot # 100706, Lot # 110709; Part # 762.025, Lot # 90611, Lot # 100218, Lot #, 110106; Part # 762.027, Lot # 100706; Part # 762.029, Lot # 90611; Part # 762.033, Lot # 90611, Lot # 91002; Part # 762.041, Lot # 90611; Part # 762.043, Lot # 90611; Part # 762.045, Lot # 90611; Part # 762.047, Lot # 90611; Part # 762.049, Lot # 90611; Part # 762.051, Lot # 90611; Part # 762.053, Lot # 90611; Part # 762.090-2.0, Lot # 100206; Part # 762.090-2.5, Lot # 100206; Part # 762.237, Lot # 91002; Part # 762.243, Lot # 91018; Part # 762.270, Lot # 91018; Part # 762.290, Lot # 91018; Part # 762.731, Lot # 91018; Part # 762.735, Lot # 91002; Part # 762.767, Lot # 91018 & Part # 762.790, Lot # 91018.
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    USA Nationwide Distribution - in the state of OH.
  • Descripción del producto
    ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfield, Ohio 44826 || Product Usage: || Device Description: The Enduramesh is a vertebral body replacement system which provides structural support of the vertebral bodies following an anterior or far lateral corpectomy, aiding in spinal fusion. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference. The Enduramesh vertebral body replacement system consists of a single cylindrically shaped titanium mesh cage. The hollow core of the cage allows for packing bone graft and the circular holes throughout the device promote bone fusions. Various diameters and heights are available to accommodate variability among patients. Indications for Use: The Enduramesh is a vertebral body replacement system intended for use in the thoracic and lumbar spine (T1-S1) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma/fracture. The device is intended for use with either allograft or autoograft. The device may be used with a cleared supplemental fixation system based on surgeon discretion and preference.
  • Manufacturer
    Lucero Medical LLC

Manufacturer

Lucero Medical LLC
  • Dirección del fabricante
    Lucero Medical LLC, 400 Wakefield Run Blvd, Hinckley OH 44233-9251
  • Empresa matriz del fabricante (2017)
    Lucero Medical LLC
  • Source
    USFDA