Z-2249-2017Class II

Arsenal Spinal Fixation System, Set Screw, Part No. 47027

Name: Z-2249-2017 Arsenal Spinal Fixation System, Set Screw, Part No. 47027
Creator: Alphatec Spine, Inc.
Published: 2017-05-05
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2017-05-05 / Terminated

FDA source

Alphatec Spine, Inc. began a recall of Arsenal Spinal Fixation System, Set Screw, Part No. 47027 Product Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal... on 2017-05-05. FDA classified it as Class II and gives the reason as "Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2249-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-05
Posted: 2017-06-06
Terminated: 2017-06-06
Recalling firm: Alphatec Spine, Inc.
Product: 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).
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall notification letter dated 5/8/17 will be sent to customers to inform them that as a result of discussions with the FDA regarding a related recall of Arsenal Set Screw part number 47127, Alphatec Spine has made the decision to recall the original Arsenal Set Screw part number 47027. This action will remove all remaining pieces of part number 47027 from the domestic (U.S.) market and the Japan market. Arsenal set screw part number 47127 was recalled in September 2016. Arsenal set screw part number 4 7027 was not included in the recall because the complaints associated with 47027 were within acceptable safety limits and remains so presently. Alphatec has received eight (8) complaints for disengagement of set screw 47027 since the product was introduced to the market on June 14, 2014, which equates to a disengagement failure rate for P/N 47027 of 0.095%. Customers are informed of the actions to be taken. Customers are instructed to fill out the last page of recall letter to confirm that you have read this notification and have taken all necessary actions as described in this notification.
Quantity in commerce: 16,959 units
Distribution: 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
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2249-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2249-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-06

Product code NKB

K133221Class IIArsenal Spinal Fixation SystemAlphatec Spine, Inc. / cleared 2014-03-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)