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U.S. Department of Health and Human Services

Class 2 Device Recall Genesys spine, Binary Screwdriver

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  Class 2 Device Recall Genesys spine, Binary Screwdriver see related information
Date Initiated by Firm November 05, 2015
Create Date October 19, 2017
Recall Status1 Terminated 3 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
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 2		 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 and Original Applicant = GENESYS SPINE
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