Recall Z-0040-2018— Genesys Orthopedics Systems, LLC

Name: FDA recall Z-0040-2018
Creator: U.S. Food and Drug Administration
Published: 2015-11-05

Class II · Terminated

Class II FDA medical device recall by Genesys Orthopedics Systems, LLC, initiated 2015-11-05, terminated 2018-07-19. It names one FDA 510(k) clearance: K133245. Product: 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.. Reason: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off..

Recalling firm: Genesys Orthopedics Systems, LLC
Classification: Class II
Status: Terminated
Initiated: 2015-11-05
Terminated: 2018-07-19
Firm location: West Lake Hills, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K133245 — GENESYS SPINE ANTERIOR CERVICAL PLATE II SYSTEMGenesys Spine·cleared 2014-10-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.