FDA Device recall Z-0040-2018
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervi…
- FDA Device
- Class II
- terminated
- Published 2017-10-25
On 2017-10-25 the FDA classified a Class II recall of Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervi… by Genesys Orthopedics Systems, citing unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0040-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-11-05 |
| Published | 2017-10-25 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Genesys Orthopedics Systems |
| Distribution | AL, FL, GA, IL, MA, MO, NY, TX |
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.
Identifiers
| code_info | Lot numbers: 10923, 109231, 11476, 11993, WT20150630A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2018%22
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