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Terminated

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.

FDA Recall Z-1989-2015 · Posted 2015-07-07

Recalling FirmAlliance Partners LLC
Recall StatusTerminated
Product CodeKWQ
Date Initiated2015-06-09
Date Terminated2015-10-09
Product Quantity21 units

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

US Nationwide Distribution in the states LA, TX, and PR.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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