Genesys spine — Class II medical device recall Z-0040-2018
Terminated recall by Genesys Orthopedics Systems, LLC, reported 2017-10-25, distributed in AL, FL, GA, IL, MA, MO, NY, TX. Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off
| Recall number | Z-0040-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genesys Orthopedics Systems, LLC, West Lake Hills, TX, United States |
| Recall initiated | 2015-11-05 |
| Classified | 2017-10-19 |
| Reported by FDA | 2017-10-25 |
| Terminated | 2018-07-19 |
| Distributed | AL, FL, GA, IL, MA, MO, NY, TX |
| Quantity | 120 units |
| Reason classes | device malfunction |
| Lot numbers | 10923, 109231, 11476, 11993, WT20150630A |
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 for recall
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.