Z-2677-2014 Class II Terminated
FDA device recall Z-2677-2014 was initiated by Genesys Orthopedics Systems, LLC on April 2, 2014 and is designated Class II. 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 u… The recall status is terminated (terminated May 15, 2015). Affected quantity: 642.
Recall Details
- Product Type
- Devices
- Report Date
- October 1, 2014
- Initiation Date
- April 2, 2014
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 642
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).
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.
Distribution Pattern
Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.
Code Information
The devices being recalled have a catalog number of G826 and a lot number of 11406.