Events

Retiro De Equipo (Recall) de Arsenal Spinal Fixation System, Set Screw, Part No. 47127

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
    75337
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0592-2017
  • Fecha de inicio del evento
    2016-10-05
  • Fecha de publicación del evento
    2016-11-16
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-02-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150094
  • 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
    Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
  • Causa
    Alphatec spine is recalling the arsenal spinal fixation system set screw due to a trend in set screw postoperative disengagement from the screw body.
  • Acción
    Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter.

Device

Arsenal Spinal Fixation System, Set Screw, Part No. 47127
  • Modelo / Serial
    Lot Numbers 695621  696252  697128  698437  700943  7689801 695622  696253  697129  698438  700944  7689802 695623  696254  697130  698439  700945  7689803 695624  696255  697131  698440  701393  7689804 695625  696256  697520  698441  701394  695626  696257  697521  698442  701395  695627  696258  697522  700611  701396  696124  696558  697523  700612  701397  696125  696574  697524  700613  701398 696126  696575  698433  700614  701399 696127  696576  698434  700615  701400 696128  696577  698435  700941  701401 696251  697127  698436  700942  701851 7878901 7829602 7766302 7766301
  • Clasificación del producto
    Orthopedic Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.
  • Descripción del producto
    Arsenal Spinal Fixation System, Set Screw, Part No. 47127 || Product Usage: Usage: || The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
  • Manufacturer
    Alphatec Spine, Inc.

Manufacturer

Alphatec Spine, Inc.
  • Dirección del fabricante
    Alphatec Spine, Inc., 5830 El Camino Real, Carlsbad CA 92008-8816
  • Empresa matriz del fabricante (2017)
    Alphatec Spine Inc
  • Source
    USFDA