Device Recall Spinal Jaxx Interbody Fusion Device

  • Modelo / Serial
    Lot 1599, Expiration date: 10/03/2018
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    The devices were distributed in California.
  • Descripción del producto
    Spinal Jaxx Interbody Fusion Device, Model: 100001-511, Size: 9 H x 10 W x 25 L || Product Usage: || The Spinal Jaxx interbody fusion device is indicated for spinal fusion for patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The indicated patient population is skeletally mature patients who have had six (6) months of non-operative treatment. The Spinal Jaxx interbody fusion device must be used with autogenous bone graft material and with supplemental fixation.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Neuropro Spinal Jaxx, 6337 Falling Brook Dr, Burke VA 22015-4031
  • Source
    USFDA