X Spine Systems Inc - Xpress System Pedicle Screw Assembly, 5.5 x 55mm - Class 2 Recall

Xpress System Pedicle Screw Assembly, 5.5 x 55mm . is an internal fixation device for spinal surgery consisting of rods, pedicle screw assemblies (screw, cap, yoke) and cross bar connector assemblies. Each Xpress pedicle screw assembly consists of a pedicle screw, yoke, screw top and threaded setscrew. The Xpress Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the Xpress Pedicle Screw System is intended to provide immobilization and stabilization of the spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoratic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
Source: Medical Device Recalls - Category: Medical Equipment Source Type: alerts