Genesys Orthopedics Systems, LLC: Medical Device Recall in 2014 - (Recall #: Z-2677-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: April 2, 2014

Date Posted: October 1, 2014

Recall Number: Z-2677-2014

Event ID: 67900

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.

Status: Terminated

Product Quantity: 642

Code Information:

The devices being recalled have a catalog number of G826 and a lot number of 11406.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated