Arsenal Spinal Fixation System — Class II medical device recall Z-0592-2017
Terminated recall by Alphatec Spine, Inc., reported 2016-11-23, distributed nationwide. Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postopera
| Recall number | Z-0592-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alphatec Spine, Inc., Carlsbad, CA, United States |
| Recall initiated | 2016-10-05 |
| Classified | 2016-11-16 |
| Reported by FDA | 2016-11-23 |
| Terminated | 2017-02-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | ES, GB, JP |
| Quantity | 16,972 units |
| Lot numbers | 695621, 695622, 695623, 695624, 695625, 695626, 695627, 696124, 696125, 696126, 696127, 696128, 696251, 696252, 696253, 696254, 696255, 696256, 696257, 696258, 696558, 696574, 696575, 696576, 696577, 697127, 697128, 697129, 697130, 697131, 697520, 697521, 697522, 697523, 697524, 698433, 698434, 698435, 698436, 698437 and 33 more |
| Model numbers | 47127 |
Product
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.
Machine access
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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.