Events

Recall of Device Recall Mac Pin NonCannulated Screw

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
    77991
  • Event Risk Class
    Class 2
  • Event Number
    Z-0325-2018
  • 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=158459
  • 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
    Thoracolumbosacral pedicle screw system - Product Code NKB
  • Reason
    Incorrect labeling for the lot of mac pins. although the pins are laser as 460 mm in length, the pins are 60 mm in length.
  • Action
    Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.

Device

Device Recall Mac Pin NonCannulated Screw
  • Model / Serial
    Model #85-6560-1, Lot #132117
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distribution to Georgia, USA.
  • Product Description
    Mac Pin Non-Cannulated Screw, 6.5 x 60mm
  • 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