Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 1, 2014
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 o
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Genesys Orthopedics Systems, LLC recalled Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys … - a moderate-severity action.
Circular Lock Screws, part # G826, lot # 11406. The Lock Screws are part of the Genesys … was recalled by Genesys Orthopedics Systems, LLC in October 1, 2014. Reason: The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine …. Check the official notice for the remedy. Verify recall #Z-2677-2014 with the FDA Devices before acting.
The recall
Genesys Orthopedics Systems, LLC issued this moderate-severity FDA Devices recall-The recall is being initiated because MK Precision (the Circular Lock Screw supplier) notified Genesys Spine ….
- Moderate
- severity level
- 642 units
- affected scope
- Class II
- classification
- October 1, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2677-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2677-2014) was formally reported on October 1, 2014, with the manufacturer initiating the action on April 2, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Genesys Orthopedics Systems, LLC is listed as the recalling firm, operating out of Austin, TX. Federal records list the affected scope as 642.
The documented reason for this recall is: 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 Stee… Distribution data in the federal record shows the product reached: Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
642
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2677-2014 |
| Date reported | October 1, 2014 |
| Date initiated | April 2, 2014 |
| Recalling firm | Genesys Orthopedics Systems, LLC |
| Firm location | Austin, TX |
| Affected scope | 642 |
| Distribution | Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2677-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Genesys Orthopedics Systems, LLC. Units affected: 642.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 1, 2014. Severity: Moderate. Recall number: Z-2677-2014.
Where was the recalled product distributed? ▼
Distribution: Nationwide Distribution including NV, CA, NY, MO, TX, FL, NJ, GA, TN..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2677-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 1, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.