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Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Sp...

FDA Device Recall #Z-0592-2017 — Class II — October 5, 2016

Recall Summary

Recall Number Z-0592-2017
Classification Class II — Moderate risk
Date Initiated October 5, 2016
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Alphatec Spine, Inc.
Location Carlsbad, CA
Product Type Devices
Quantity 16,972 units

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.

Distribution Pattern

Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.

Lot / Code Information

Lot Numbers 695621 696252 697128 698437 700943 7689801 695622 696253 697129 698438 700944 7689802 695623 696254 697130 698439 700945 7689803 695624 696255 697131 698440 701393 7689804 695625 696256 697520 698441 701394 695626 696257 697521 698442 701395 695627 696258 697522 700611 701396 696124 696558 697523 700612 701397 696125 696574 697524 700613 701398 696126 696575 698433 700614 701399 696127 696576 698434 700615 701400 696128 696577 698435 700941 701401 696251 697127 698436 700942 701851 7878901 7829602 7766302 7766301

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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