Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 25, 2017
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc di
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Genesys Orthopedics Systems, LLC recalled Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plat… - a moderate-severity action.
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plat… was recalled by Genesys Orthopedics Systems, LLC in October 25, 2017. Reason: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break of…. Check the official notice for the remedy. Verify recall #Z-0040-2018 with the FDA Devices before acting.
The recall
Genesys Orthopedics Systems, LLC issued this moderate-severity FDA Devices recall-Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break of….
- Moderate
- severity level
- 120 units
- affected scope
- Class II
- classification
- October 25, 2017
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0040-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0040-2018) was formally reported on October 25, 2017, with the manufacturer initiating the action on November 5, 2015. 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 West Lake Hills, TX. Federal records list the affected scope as 120 units.
The documented reason for this recall is: Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off. Distribution data in the federal record shows the product reached: US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO. 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
120 units
Related Recalls
6
3 from same agency
Product description
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.
Reason for recall
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0040-2018 |
| Date reported | October 25, 2017 |
| Date initiated | November 5, 2015 |
| Recalling firm | Genesys Orthopedics Systems, LLC |
| Firm location | West Lake Hills, TX |
| Affected scope | 120 units |
| Distribution | US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO |
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-0040-2018) 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? ▼
Genesys spine, Binary Screwdriver, GCP221, component of the Binary Anterior Cervical Plating System The Genesys Spine Binary Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), spondylolisthesis, trauma (i.e. fractures or dislocations), tumors, deformity (defined as kyphosis, lordosis, or scoliosis),pseudoarthrosis, failed previous fusion, and/or spinal stenosis.. Recalled by Genesys Orthopedics Systems, LLC. Units affected: 120 units.
Why was this product recalled? ▼
Unanticipated technique for a cervical screw insertion caused the tip of the threaded inner shaft to break off.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 25, 2017. Severity: Moderate. Recall number: Z-0040-2018.
Where was the recalled product distributed? ▼
Distribution: US Distribution to the states of : FL, TX, NY, IL, GA, AL, MA, MO.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0040-2018) 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 25, 2017. 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.