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Recall Observatory FDA recall evidence

Device 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.

Z-0040-2018

November 05, 2015

Class II

Product summary

Firm
Genesys Orthopedics Systems, LLC
Event
Event 78181
Status
Terminated
Classification
Class II
Quantity
120 units
Official record key
device-enforcement:Z-0040-2018

Official wording

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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