|Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW
Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW
Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW
Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW
Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com
Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000.
The Stryker Spine Trio/Trio+ Spinal Fixation Systems are comprised of spinal screws, rods, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
||Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows:
48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201
48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197
48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198
48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599
48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
||The front cover of Instructions For Use (IFU) #NOLI135B03Rev02 was improperly marked with a "Sterile" logo in the lower right corner. The products these IFUs were packed with are sold as "Non-Sterile" and require sterilization before use in surgery.