Alliance Partners LLC: Medical Device Recall in 2015 - (Recall #: Z-1989-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: June 9, 2015

Date Posted: July 15, 2015

Recall Number: Z-1989-2015

Event ID: 71457

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.

Status: Terminated

Product Quantity: 21 units

Code Information:

Lot numbers SM59161 and SM60278

Distribution Pattern:

US Nationwide Distribution in the states LA, TX, and PR.

Voluntary or Mandated:

Voluntary: Firm initiated