Device Recall Zodiac Polyaxial Spinal Fixation System

  • Model / Serial
    Part Number: 62665-50 Lot Number: 617945
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    AZ, CA, FL, TX
  • Product Description
    Zodiac Polyaxial Spinal Fixation System. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Alphatec Spine, Inc., 2051 Palomar Airport Rd Ste 100, Carlsbad CA 92011-1462
  • Manufacturer Parent Company (2017)
  • Source
    USFDA