Events

Recall of Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm

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

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
    77986
  • Event Risk Class
    Class 2
  • Event Number
    Z-0316-2018
  • Event Initiated Date
    2017-07-07
  • 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=158455
  • 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
    Intervertebral fusion device with integrated fixation, cervical - Product Code OVE
  • Reason
    Incorrect direct marking and color identification for the affected lot of ceres self-drilling variable screws. although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
  • Action
    The firm, Amendia, sent an "URGENT: MEDICAL DEVICE RECALL" letter to its Customers. The letter described the product, problem and actions to be taken. The customers were Instructed to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia by emailing: jconover@amendia.com or call 770-575-5236 or jwilliamson@amendia or call 770-575-5369, and to complete and return the Response Form. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

Device

Device Recall Ceres SelfDrilling Variable Screw 4.0 x 12mm
  • Model / Serial
    Model # 12-31-4012, Lot #133039
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to states of: AL, FL, GA, NY, TX, and VA.
  • Product Description
    Ceres Self-Drilling Variable Screw 4.0 x 12mm || The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
  • Manufacturer
    Amendia, Inc

Manufacturer

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