Events

Recall of Device Recall Omni Spine Anterior Cervical Plate System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Amendia, Inc dba Spinal Elements.

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
    78592
  • Event Risk Class
    Class 2
  • Event Number
    Z-0239-2018
  • Event Initiated Date
    2017-11-13
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=159848
  • 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
    Potential incorrect marking and color identification of piranha screw. some screws marked as 12 mm actually measure 14 mm.
  • Action
    Spinal Elements sent an Urgent Medical Device Recall letter dated November 13, 2017. Instructions included to examine inventory and quarantine affected products, complete and return the response form, arrange for return of any affected product, and to notify customers if further distributed. For further questions, please call (770) 575-5274.

Device

Device Recall Omni Spine Anterior Cervical Plate System
  • Model / Serial
    Part No. CSF-40-12, Lot No. 132635
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : AR, CA, GA, LA, MD, NV, NY, OH and TX.
  • Product Description
    Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System || The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Omni Spine Anterior Cervical Plate System. The Omni Spine Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) as an adjustment to fusion in the treatment of degenerative disc disease (DDD), sponylolisthesis, spinal stenosis, tumors, trauma (i.e. fracture).
  • Manufacturer
    Amendia, Inc dba Spinal Elements

Manufacturer

Amendia, Inc dba Spinal Elements
  • Manufacturer Address
    Amendia, Inc dba Spinal Elements, 1755 W Oak Pkwy, Marietta GA 30062-2260
  • Manufacturer Parent Company (2017)
    Spinal Elements
  • Source
    USFDA