Genesys Orthopedics Systems, LLC: Medical Device Recall in 2017 - (Recall #: Z-0040-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 5, 2015

Date Posted: October 25, 2017

Recall Number: Z-0040-2018

Event ID: 78181

Reason for Recall:

Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.

Status: Terminated

Product Quantity: 120 units

Code Information:

Lot numbers: 10923, 109231, 11476, 11993, WT20150630A

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated