Device Recall Omni Spine Anterior Cervical Plate System

Part No. CSF-40-12, Lot No. 132635

Orthopedic Devices

2

Yes

US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.

Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).