The TiLock Pedicle Screw System

  • Modelo / Serial
    The devices being recalled have a catalog number of G826 and a lot number of 11406.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
  • Descripción del producto
    Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System. || The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Genesys Orthopedics Systems, LLC, 1250 S Capital Of Texas Hwy, Bldg #3, Suite 600, Austin TX 78746-6446
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA