Events

Recall of Device Recall NakomaSL ACP System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Alliance Partners LLC.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    71457
  • Event Risk Class
    Class 2
  • Event Number
    Z-1989-2015
  • Event Initiated Date
    2015-06-09
  • Event Date Posted
    2015-07-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137878
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Appliance, fixation, spinal intervertebral body - Product Code KWQ
  • 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.
  • 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.

Device

Device Recall NakomaSL ACP System
  • Model / Serial
    Lot numbers SM59161 and SM60278
  • Product Classification
    Orthopedic Devices
  • 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
    Alliance Partners LLC

Manufacturer

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