Class 2 Device Recall The TiLock Pedicle Screw System

• Date Initiated by Firm: April 02, 2014
• Date Posted: September 22, 2014
• Recall Status: Terminated on May 15, 2015
• Recall Number: Z-2677-2014
• Recall Event ID: 67900
• 510(K)Number: K100757
• Product Classification: Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
• Product: Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle Screw System.; The TiLock Pedicle Screw System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion).
• Code Information: The devices being recalled have a catalog number of G826 and a lot number of 11406.
• Recalling Firm/ Manufacturer: Genesys Orthopedics Systems, LLC; 1250 S Capital Of Texas Hwy; Bldg #3, Suite 600; Austin TX 78746-6446
• For Additional Information Contact: 512-381-7070
• Manufacturer Reason for Recall: The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine that a portion (less than 20%) of the Circular Lock Screws in lot 11406 were manufactured using Stainless Steel in the center Post instead of the specified titanium alloy.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Genesys Spine sent an Urgent Medical Device Recall letter dated April 2, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine their inventory and quarantine any affected product. Customers were instructed to notify their customers (end users) of the recall and request that they return any affected product to Genesys Spine by completing the attached Recall Tracking Form to Genesys Spine, 1250 South Capital of Texas Hwy, Building Three, Suite 600, Austin, Texas 78746. Customers with questions were instructed to call 512-381-7070.
• Quantity in Commerce: 642
• Distribution: Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
• 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 = NKB and Original Applicant = GENESYS SPINE