Device Recall Genesys spine, Binary Screwdriver

  • Model / Serial
    Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
  • Product Description
    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
  • 1 Event

Manufacturer

  • Manufacturer Address
    Genesys Orthopedics Systems, LLC, 1250 S Capital of Texas Hwy Ste 600, Bldg # 3, West Lake Hills TX 78746-6446
  • Manufacturer Parent Company (2017)
  • Source
    USFDA