Device Recall Alphatec Souls Proximal/Distal Deployment Wrench

Part Numbers: 25975 & 25976. Product Code(s): MAX. Market Clearance: 510(k) K102402.

Orthopedic Devices

2

Yes

Worldwide Distribution - USA (nationwide) and Germany

SOLUS Anterior Lumbar Interbody Fusion Spinal || Spacer System, Solus Proximal/Distal Deployment Wrenches, 510(k) K102402. || The Alphatec Solus Anterior Lumbar Interbody Fusion (AUF) System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DOD) at one or two contiguous levels from L2-S1 with up to Grade 1 spondyiolisthesis or retrolisthesis at the involved level(s). DOD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. The Alphatec Solus implant is intended to be used with autograft. The device is intended for use with supplemental fixation that is in addition to the integrated blades. The Alphatec Solus implant is intended for use with supplemental spinal fixation. Specifically, the Alphatec Solus implant is to be used with the Alphatec's Zodiac¿ Spinal Fixation System, Aspida" Anterior Lumbar Plating System, or the ILLlCO¿ MIS Posterior Fixation System. Intervertebral body fusion device.