Alphatec Spine, Inc. - Solanas 2.1mm FIXED DEPTH DRILL, 10mm - Class 2 Recall

Solanas 2.1mm FIXED DEPTH DRILL, 10mm , Part No. 63928-10 The SOLANAS III Posterior Stabilization System is a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3). It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (TI -T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine. The components in the Solanas Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods: -Degenerative disk disease (DDD), defined as neck pain of discogenic origin with degeneration of the disc confinmed by history and radiographic studies -Spondylolisthesis -Spinal Stenosis -Fracture/Dislocation - Atlanto/Axial fracture with instability
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts