# FDA recall Z-0040-2018

> **Genesys Orthopedics Systems, LLC** · Class II · device recall initiated 2015-11-05.

## 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.

## Distribution

US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO

## Key facts

- **Recall number:** Z-0040-2018
- **Recalling firm:** Genesys Orthopedics Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-11-05
- **Report date:** 2017-10-25
- **Termination date:** 2018-07-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** West Lake Hills, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0040-2018

## Citation

> AI Analytics. FDA recall Z-0040-2018. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0040-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*