Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating Syst...
FDA Device Recall #Z-0040-2018 — Class II — November 5, 2015
Recall Summary
| Recall Number | Z-0040-2018 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 5, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Genesys Orthopedics Systems, LLC |
| Location | West Lake Hills, TX |
| Product Type | Devices |
| Quantity | 120 units |
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.
Distribution Pattern
US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
Lot / Code Information
Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
Other Recalls from Genesys Orthopedics Systems, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2677-2014 | Class II | Circular Lock Screws, part # G826, lot # 11406.... | Apr 2, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.