Circular Lock Screws — Class II medical device recall Z-2677-2014
Terminated recall by Genesys Orthopedics Systems, LLC, reported 2014-10-01, distributed nationwide. The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine t
| Recall number | Z-2677-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Genesys Orthopedics Systems, LLC, Austin, TX, United States |
| Recall initiated | 2014-04-02 |
| Classified | 2014-09-22 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 642 |
| Lot numbers | 11406 |
| Model numbers | G826 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2677-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.