Genesys Orthopedics Systems, LLC recalls Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine B…

Recall date

November 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0040-2018

FDA classification

Class II

Brand / firm

Genesys Orthopedics Systems, LLC

Sold / distributed

US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO

Why it was recalled

Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.