FDA Device recall Z-2677-2014
Circular Lock Screws, part # G826, lot # 11406
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of Circular Lock Screws, part # G826, lot # 11406 by Genesys Orthopedics Systems, citing 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 1140….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2677-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-02 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Genesys Orthopedics Systems |
| Distribution | US |
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).
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.
Identifiers
| code_info | The devices being recalled have a catalog number of G826 and a lot number of 11406. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2677-2014%22
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