Device Recall NakomaSL ACP System

  • Model / Serial
    Lot numbers SM59161 and SM60278
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution in the states LA, TX, and PR.
  • 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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Alliance Partners LLC, 121 Interpark Blvd Ste 601, San Antonio TX 78216-1842
  • Manufacturer Parent Company (2017)
  • Source
    USFDA