Events

Retiro De Equipo (Recall) de Novel VBR Spinal 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 Alphatec Spine, 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
    48177
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0508-2009
  • Fecha de inicio del evento
    2007-08-16
  • Fecha de publicación del evento
    2008-12-31
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2009-01-12
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74679
  • 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
    Firm confirmed that two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. they were incorrectly laser marked with the wrong part numbers and sizes. two lots were mixed from the following lot numbers: part number 64733-120 lot number 611884, and part number 64753-126 and lot number 611881.
  • Acción
    The recall was initiated on August 16, 2007 with Alphatec Spine contacting each of the four direct distributors by telephone. This was followed with a Product Recall Notice, dated August 27, 2007, that was mailed to all affected customers. The distributors were informed that the firm was conducting a voluntary recall because two lots were mixed during manufacturing and were incorrectly labeled with the wrong part number & lot number. The firm asked the customers to return the product, and were informed that replacement product will be sent back.

Device

Novel VBR Spinal System
  • Modelo / Serial
    Lot Number: 611881
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution --- including states of AZ, FL, NY & TX.
  • Descripción del producto
    Novel PEEK VBR XS 16-22 MM, S-5, 26MM, Part Numbers : 64753-126. || Indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e., fracture). Intended for use with supplemental spinal fixation systems.
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Dirección del fabricante
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Empresa matriz del fabricante (2017)
    Alphatec Spine Inc
  • Source
    USFDA