Class 2 Device Recall Genesys spine, Binary Screwdriver

• Date Initiated by Firm: November 05, 2015
• Create Date: October 19, 2017
• Recall Status: Terminated on July 19, 2018
• Recall Number: Z-0040-2018
• Recall Event ID: 78181
• 510(K)Number: K133245
• Product Classification: Screwdriver, surgical - Product Code LRZ
• 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.
• Code Information: Lot numbers: 10923, 109231, 11476, 11993, WT20150630A
• FEI Number: 3008455034
• Recalling Firm/ Manufacturer: Genesys Orthopedics Systems, LLC; 1250 S Capital of Texas Hwy Ste 600 ; Bldg # 3; West Lake Hills TX 78746-6446
• For Additional Information Contact: 512-381-7070
• Manufacturer Reason for Recall: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
• FDA Determined Cause: Component design/selection
• Action: Genesys Spine initiated their field action on November 15, 2015, by letter. The letter explained how and why the instrument failed and provided updated instructions on how the instrument was to be used. Consignees were provided the option to exchange the unit for another model. The firm expanded the action on September 22, 2017, to request the return of the product. On September 27, 2017, the firm sent a notice to three distributors who were not identified in the original group of consignees. For further questions, please call (512) 381-7070.
• Quantity in Commerce: 120 units
• Distribution: US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LRZ