FDA Medical Device Recalls (openFDA)
Genesys Orthopedics Systems, LLC: 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).
- Recall number
- Z-2677-2014
- Recalling firm
- Genesys Orthopedics Systems, LLC
- 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).
- Status
- Terminated
- Initiated
- 2014-04-02
- Posted
- 2014-09-22
- Terminated
- 2015-05-15
- Reason
- 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.
- Root 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
- 642
- Distribution
- Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
- Lot, serial or model codes
- The devices being recalled have a catalog number of G826 and a lot number of 11406.
- 510(k) numbers
- ["K100757"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3008455034
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28