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Alliance Partners LLC recalls Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP Sys
Recalled July 15, 2015 · FDA recall Z-1989-2015 · Alliance Partners
Hazard
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 Class II
Units
21 units
Sold at
US Nationwide Distribution in the states LA, TX, and PR.
Description
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.
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.
Manufacturer(s)
Alliance Partners LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →