Events

Recall of Device Recall CeresC Standalone Cervical Interbody, absent the tantalum market pin

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
    75857
  • Event Risk Class
    Class 2
  • Event Number
    Z-0966-2017
  • Event Initiated Date
    2016-11-22
  • Event Date Posted
    2017-01-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151460
  • 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
    Absent tantalum market pin.
  • Action
    The firm, Amendia, contacted the consignee and issued a Return Material Authorization for the affected product on 8/18/2016. Please contact Regulatory and Quality Consultant for Amendia at 404-610-7215 or by email to bbrosseau@securebme.com with any questions or concerns regarding this recall notification.

Device

Device Recall CeresC Standalone Cervical Interbody, absent the tantalum market pin
  • Model / Serial
    Part Number 08-170-1010 - Lot Number 134926; Part Number 08-170-1011 - Lot Number 134927; Part Number 08-170-1006 - Lot Number 134929; Part Number 08-170-1008 - Lot Number 134931
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to GA only.
  • Product Description
    Ceres-C Standalone Cervical Interbody || The product is a stand-alone anterior cervical interbody fusion device indicated for use in skeletally mature patients with degenerative disc disease (DDD) with accompanying radicular symptoms at the one level from C2-T1.
  • 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