Z-2677-2014Class II

Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle...

Name: Z-2677-2014 Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys Spine TiLock Pedicle...
Creator: Genesys Orthopedics Systems, LLC
Published: 2014-04-02
License: https://open.fda.gov/license/

Genesys Spine / initiated 2014-04-02 / Terminated / root cause: manufacturing process

FDA source

Genesys Orthopedics Systems, LLC began a recall of 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... on 2014-04-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2677-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-02
Posted: 2014-09-22
Terminated: 2015-05-15
Recalling firm: Genesys Spine
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).
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 642
Distribution: Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
Product codes and lots: The devices being recalled have a catalog number of G826 and a lot number of 11406.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2677-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2677-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-22

Product code NKB

K100757Class IITilock Pedicle Screw SystemGenesys Spine / cleared 2010-07-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)