Device Recall Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690

  • Modelo / Serial
    Part number 03.809.690, Lot Number 6723847
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA including CO, PA, TN, VA, TN, WA, and internationally to Czech Republic.
  • Descripción del producto
    Synthes Oracle Spacer System Slap Hammer, Part Number 03.809.690, Lot Number 3723847 || The Oracle Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The Oracle Spacer is indicated as a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a diseased vertebral body resected or excised during partial and total vertebrectomy procedures or the treatment of tumor or trauma (i.e., fracture), to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of the collapsed vertebral body. The Slap Hammer, 03.809.690, is a dual sided device with two separate attachment options. The Slap Hammer allows a user (surgeon) to remove a previously placed trial implants.
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
    Synthes USA HQ, Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Empresa matriz del fabricante (2017)
  • Source