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Terminated

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).

FDA Recall Z-2677-2014 · Posted 2014-09-22

Recalling FirmGenesys Orthopedics Systems, LLC
Recall StatusTerminated
Product CodeNKB
Date Initiated2014-04-02
Date Terminated2015-05-15
Product Quantity642

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K100757TILOCK PEDICLE SCREW SYSTEMGenesys Spine · 2010-07-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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