CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Arsenal Spinal Fixation System, Set Screw recalled by Alphatec Spine

Alphatec Spine is recalling Arsenal Spinal Fixation System, Set Screw, distributed nationwide in the US. The recall was initiated on 5 May 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057

Quantity recalled16,959 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2249-2017
FDA event ID: 77220
Recalling firm: Alphatec Spine, Carlsbad, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2017
FDA classified: 6 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

5 May 2017	Recall initiated by company
6 Jun 2017	Classified by FDA	+32 days
14 Jun 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product 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 ELl). The rods are available in commercially pure titanium, titanium alloy, and cobalt chrome (CP Ti Grade 4, Ti-6AI-4V ELl, and Co-28Cr-6Mo).

Where it was distributed

Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan

Nationwide Alabama Arizona California Colorado Florida Iowa Kentucky Michigan Minnesota Nevada Ohio Oklahoma Puerto Rico South Dakota Texas Utah Virginia

Questions about this recall

Is Arsenal Spinal Fixation System, Set Screw recalled?

Yes. Alphatec Spine recalled Arsenal Spinal Fixation System, Set Screw on 5 May 2017. The recall is Class II and its status is Terminated. Recall number Z-2249-2017.

Why was it 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 lots are affected?

671949 681640 684646 687843 690206 692720 693064 671948 681641 684646 687843 690206 692705 674136 681642 684647 687847 690210 692718 674137 682061 686374 687847 691848S1 692719 674431 682060 684645 689847 691848 692855 674432 682062 686372 689847 691849 692855 674433 682063 686375 689849 692597 692706 671950 684429 687839 690127 692597 692864 674429 684430 687839 689848 692364 692910 674430 684432 687840 690207 692598 692911 681638S1 684644 687840 690207 691590 692911 681638 684433 687842 690208 692599 693065 681639 684431 687845 690209 692704 693057

Where was it sold?

Worldwide Distribution - US Nationwide in the states of (TX, AL, UT, FL, IA, SD, NV, OH, CA, MN, CO, AZ, OK, MI, VA, KY, and Puerto Rico) and country of Japan

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Alphatec Spine

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5 Feb 2025Device	CLASS II	Calibrate CCX Interbody System for spinal fusion procedures recalled	Alphatec Spine	Sterility	Nationwide
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