Alphatec Spine, Inc.: 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).

Recall number

Z-2249-2017

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).

Status

Terminated

Initiated

2017-05-05

Posted

not on file

Terminated

2017-06-06

Reason

Alphatec Spine is recalling the Arsenal Spinal Fixation System Set Screw due to a trend in set screw postoperative disengagement from the screw body.

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

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

Lot, serial or model codes

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

510(k) numbers

["K133221"]

PMA numbers

not on file

Product code

NKB

Firm FEI

2027467

Firm city

Carlsbad

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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