Z-0040-2018 Class II Terminated
FDA device recall Z-0040-2018 was initiated by Genesys Orthopedics Systems, LLC on November 5, 2015 and is designated Class II. Reason for recall: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. The recall status is terminated (terminated July 19, 2018). Affected quantity: 120 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2017
- Initiation Date
- November 5, 2015
- Termination Date
- July 19, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 120 units
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.
Reason for Recall
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Distribution Pattern
US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
Code Information
Lot numbers: 10923, 109231, 11476, 11993, WT20150630A