Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Recalled by Alliance Partners LLC Due to Inadequate interference between the screw and the plate...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Alliance Partners LLC directly.
Affected Products
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.
Quantity: 21 units
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Alliance Partners LLC
Alliance Partners LLC has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report