Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 23, 2016
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass developmen
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Alphatec Spine, Inc. recalled Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Ar… - a moderate-severity action.
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Ar… was recalled by Alphatec Spine, Inc. in November 23, 2016. Reason: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoper…. Check the official notice for the remedy. Verify recall #Z-0592-2017 with the FDA Devices before acting.
The recall
Alphatec Spine, Inc. issued this moderate-severity FDA Devices recall-Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoper….
- Moderate
- severity level
- 17K units
- affected scope
- Class II
- classification
- November 23, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0592-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0592-2017) was formally reported on November 23, 2016, with the manufacturer initiating the action on October 5, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Alphatec Spine, Inc. is listed as the recalling firm, operating out of Carlsbad, CA. Federal records list the affected scope as 16,972 units.
The documented reason for this recall is: Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body. Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.. 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
16,972 units
Related Recalls
6
3 from same agency
Product description
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).
Reason for recall
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0592-2017 |
| Date reported | November 23, 2016 |
| Date initiated | October 5, 2016 |
| Recalling firm | Alphatec Spine, Inc. |
| Firm location | Carlsbad, CA |
| Affected scope | 16,972 units |
| Distribution | Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain. |
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-0592-2017) 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? ▼
Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for the treatment of degenerative disease, deformity, and trauma indications. The Arsenal System consists of a variety of shapes and sizes of rods, screws, hooks, connectors, and bridges that provide temporary internal fixation and stabilization during bone graft healing and/or fusion mass development. The screws, hooks, connectors, and bridges are manufactured from surgical grade titanium alloy (Ti-6AI-4V ELI). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6Al-4V ELI, and Co-28Cr-6Mo).. Recalled by Alphatec Spine, Inc.. Units affected: 16,972 units.
Why was this product recalled? ▼
Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2016. Severity: Moderate. Recall number: Z-0592-2017.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0592-2017) 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 November 23, 2016. 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.