Z-1989-2015Class II

Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide

Name: Z-1989-2015 Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide
Creator: Alliance Partners LLC
Published: 2015-06-09
License: https://open.fda.gov/license/

Alliance Partners, LLC / initiated 2015-06-09 / Terminated / root cause: design

FDA source

Alliance Partners LLC began a recall of Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral... on 2015-06-09. FDA classified it as Class II and gives the reason as "Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1989-2015
Classification: Class II
Status: Terminated
Initiated: 2015-06-09
Posted: 2015-07-07
Terminated: 2015-10-09
Recalling firm: Alliance Partners, LLC
Product: Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease, Trauma, Tumors, Deformities or curvatures, Psuedoarthrosis, Failed previous fusions, Spondylolistesis, and Spinal Stenosis.
Product code: KWQ Appliance, Fixation, Spinal Intervertebral Body
Reason for recall: Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
Root cause tag: design
FDA root cause: Device Design
Action: Alliance Spine sent an Urgent Medical Device Field Action Notification letter dated June 15, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form and fax to 210-314-2524.
Quantity in commerce: 21 units
Distribution: US Nationwide Distribution in the states LA, TX, and PR.
Product codes and lots: Lot numbers SM59161 and SM60278

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1989-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1989-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-15	2015-07-07

Product code KWQ

K141993Class IINakoma AcpAlliance Partners, LLC / cleared 2014-11-06

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)