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.
Recall
- Recall Number
- Z-0040-2018
- Event Number
- 78181
- Firm
- Genesys Orthopedics Systems, LLC 1250 S Capital of Texas Hwy Ste 600 Bldg # 3 West Lake Hills TX 78746-6446
- FEI Number
- 3008455034
- Product Code
- LRZ
- Status
- Terminated
- Root Cause
- Component design/selection
- Initiated
- November 5, 2015
- Terminated
- July 19, 2018
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.
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070.
US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
120 units