Events

Recall of Device Recall Invue Screws

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by SpineFrontier, 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
    66914
  • Event Risk Class
    Class 2
  • Event Number
    Z-0575-2014
  • Event Initiated Date
    2013-11-20
  • Event Date Posted
    2013-12-26
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124183
  • 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
    Mismarked and unmarked screws.
  • Action
    On 11/20/2013, consignees were notified of the email via letter. Consignees were instructed to return the screws listed in the recall notification letter and return the Recall Acknowledgement form to SpineFrontier via fax or email.

Device

Device Recall Invue Screws
  • Model / Serial
    Lot/Serial Number: IM71 0 16-01: Lots 0000, 000 1
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution- including DC and the states of OH, TX, KS, MA, IN, CO, NY, AL, and MI.
  • Product Description
    Indus Invue Screws: IM71016-XX: 04.5mm, SelfTapping. || Used to secure the Invue Anterior Cervical Plate in position.
  • Manufacturer
    SpineFrontier, Inc.

Manufacturer

SpineFrontier, Inc.
  • Manufacturer Address
    SpineFrontier, Inc., 500 Cummings Ctr Ste 3500, Beverly MA 01915-6516
  • Manufacturer Parent Company (2017)
    SpineFrontier, Inc.
  • Source
    USFDA