Events

Recall of Device Recall Optimus Fixed Awl

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
    75856
  • Event Risk Class
    Class 2
  • Event Number
    Z-0891-2017
  • Event Initiated Date
    2016-11-22
  • Event Date Posted
    2016-12-22
  • 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=151458
  • 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, lumbar - Product Code OVD
  • Reason
    Complaints that the tip of the awl broke after impaction during surgery.
  • Action
    Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions, please call (404) 610-7215.

Device

Device Recall Optimus Fixed Awl
  • Model / Serial
    Part Number 139005 - Lot Number 182-16146
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Distribution to the states of : FL, GA. IL, MO, TX
  • Product Description
    Optimus Fixed Awl
  • 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