Events

Retiro De Equipo (Recall) de Device Recall Genesys spine, Binary Screwdriver

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 Genesys Orthopedics Systems, 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
    78181
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0040-2018
  • Fecha de inicio del evento
    2015-11-05
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2018-07-19
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158848
  • 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
    Screwdriver, surgical - Product Code LRZ
  • Causa
    Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
  • Acción
    Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070.

Device

Device Recall Genesys spine, Binary Screwdriver
  • Modelo / Serial
    Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
  • Clasificación del producto
    General and Plastic Surgery Devices
  • Clase de dispositivo
    1
  • ¿Implante?
    No
  • Distribución
    US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
  • Descripción del producto
    Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System || The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
  • Manufacturer
    Genesys Orthopedics Systems, LLC

Manufacturer

Genesys Orthopedics Systems, LLC
  • Dirección del fabricante
    Genesys Orthopedics Systems, LLC, 1250 S Capital of Texas Hwy Ste 600, Bldg # 3, West Lake Hills TX 78746-6446
  • Empresa matriz del fabricante (2017)
    Genesys Orthopedics Systems LLC
  • Source
    USFDA