Recall Z-1989-2015— Alliance Partners LLC

Name: FDA recall Z-1989-2015
Creator: U.S. Food and Drug Administration
Published: 2015-06-09

Class II · Terminated

Class II FDA medical device recall by Alliance Partners LLC, initiated 2015-06-09, terminated 2015-10-09. It names one FDA 510(k) clearance: K141993. 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.. Reason: 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..

Recalling firm: Alliance Partners LLC
Classification: Class II
Status: Terminated
Initiated: 2015-06-09
Terminated: 2015-10-09
Firm location: San Antonio, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K141993 — NAKOMA ACPAlliance Partners, LLC·cleared 2014-11-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.