Recall Z-1989-2015 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
Alliance Partners LLC
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: Degenera
| Date | Jul 7, 2015 (initiated Jun 9, 2015) |
| Status | Terminated |
| 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. |
| Root 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 | 21 units |
| Distribution | US Nationwide Distribution in the states LA, TX, and PR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141993 | NAKOMA ACP Alliance Partners, LLC, Nov 6, 2014 |