Circular Lock Screws, part # G826, lot # 11406. The Lock… recallZ-2677-2014 · Genesys Orthopedics Systems, LLC · initiated Apr 2, 2014
Class II Terminated All recalls posted in September 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Genesys Orthopedics Systems, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2677-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 2, 2014
- Posted by the FDA
- Sep 22, 2014
- Recalling firm
- Genesys Orthopedics Systems, LLC
- Quantity
- 642
- Product code
- NKB
- FDA submissions
- K100757
- Distribution
- Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
Product description
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 (models, lots, serial numbers)
The devices being recalled have a catalog number of G826 and a lot number of 11406.
Other devices under the same FDA submission
3 devices cleared under K100757 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TiLock 1Genesys Orthopedics Systems LLC · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 report
- TiLock 1Genesys Orthopedics Systems LLC · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 report
- TiLock 1Genesys Orthopedics Systems LLC · Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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