Recall of Device Recall Tipped Tapered Solid Driver (Screwdriver)

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Screwdriver - Product Code HXX
  • Reason
    The nipple of the tipped driver broke off when surgeons were attempting to insert the screw.
  • Action
    On May 9, 2012 an email was sent to consignees requesting that the product be returned for servicing and that a replacement part would be sent.


  • Model / Serial
    Lot Number: 011836-0001, 011981-001
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Distributed in DC and the states of MA, and OK.
  • Product Description
    Invue Solid Driver, Tipped, AO. Part Number: 11-70083. || Allows the user to retain the screw when changing axis of insertion during fixation of spinal intervertebral.
  • Manufacturer


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