Z-1989-2015 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 15, 2015
- Initiation Date
- June 9, 2015
- Termination Date
- October 9, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
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.
Distribution Pattern
US Nationwide Distribution in the states LA, TX, and PR.
Code Information
Lot numbers SM59161 and SM60278