FDAJune 9, 2015device

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 spin...

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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