Z-0592-2017Class II

Arsenal Spinal Fixation System, Set Screw, Part No. 47127

Name: Z-0592-2017 Arsenal Spinal Fixation System, Set Screw, Part No. 47127
Creator: Alphatec Spine, Inc.
Published: 2016-10-05
License: https://open.fda.gov/license/

Alphatec Spine, Inc. / initiated 2016-10-05 / Terminated

FDA source

Alphatec Spine, Inc. began a recall of Arsenal Spinal Fixation System, Set Screw, Part No. 47127 Product Usage: Usage: The Arsenal Spinal Fixation System is intended for posterior, non-cervical... on 2016-10-05. 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-0592-2017
Classification: Class II
Status: Terminated
Initiated: 2016-10-05
Posted: 2016-11-16
Terminated: 2017-02-17
Recalling firm: Alphatec Spine, Inc.
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).
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: Alphatae Spine sent an Urgent Medical Device Recall notification letter dated September 29, 2016 to customers. The letter identified the affected product, problem and the actions to be taken. Customers are instructed to fill out and return the last page of recall letter using one of the methods identified in the letter.
Quantity in commerce: 16,972 units
Distribution: Worldwide Distribution - US Nationwide in the countries of Japan, UK, NSW, Spain.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0592-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2017	Class II	Terminated	Voluntary: Firm initiated	2016-11-23	2016-11-16

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)