Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Genesys spine Recalled by Genesys Orthopedics Systems, LLC Due to Unanticipated technique for a cervical screw insertion caused...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Genesys Orthopedics Systems, LLC directly.
Affected Products
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Quantity: 120 units
Why Was This Recalled?
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Where Was This Sold?
This product was distributed to 8 states: AL, FL, GA, IL, MA, MO, NY, TX
About Genesys Orthopedics Systems, LLC
Genesys Orthopedics Systems, LLC has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report