Events

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
    Recall
  • Event ID
    64994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1957-2013
  • Event Initiated Date
    2012-05-09
  • Event Date Posted
    2013-08-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-01-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117613
  • 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.

Device

Device Recall Tipped Tapered Solid Driver (Screwdriver)
  • Model / Serial
    Lot Number: 011836-0001, 011981-001
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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
    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