Class 2 Device Recall NakomaSL ACP System

• Date Initiated by Firm: June 09, 2015
• Date Posted: July 07, 2015
• Recall Status: Terminated on October 09, 2015
• Recall Number: Z-1989-2015
• Recall Event ID: 71457
• 510(K)Number: K141993
• Product Classification: Appliance, fixation, spinal intervertebral body - Product Code KWQ
• 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.
• Code Information: Lot numbers SM59161 and SM60278
• FEI Number: 3008520015
• Recalling Firm/ Manufacturer: Alliance Partners LLC; 121 Interpark Blvd Ste 601; San Antonio TX 78216-1842
• For Additional Information Contact: Kristiina Gilkey; 210-314-2525 Ext. 213
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KWQ