Events

Recall of Device Recall SpineFrontier PedFuse Pedicle Screw System

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
    70065
  • Event Risk Class
    Class 2
  • Event Number
    Z-0977-2015
  • Event Initiated Date
    2014-12-19
  • Event Date Posted
    2015-01-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-01-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132251
  • 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
    Orthopedic manual surgical instrument - Product Code LXH
  • Reason
    A crack may develop in the handle to the inline persuader, which may progress if the user continues to use the affected instrument.
  • Action
    Spinefrontier sent an Urgent Voluntary Recall Notification letter dated December 16, 2015, to all affected customers. The notice informed customers of the recall and requests that they initiate the immediate return of the parts listed. In addition, SpineFrontier is requiring confirmation via recall acknowledgement form that consignees have received this notice and that they will initiated the immediate return of the parts. Customers can contact SpineFrontier at 978-232-3990 Monday through Friday 8:30AM to 5:30PM EST with any questions.

Device

Device Recall SpineFrontier PedFuse Pedicle Screw System
  • Model / Serial
    Lot/Serial Numbers: 06440-0000, 06441-0000, AG24
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including TX, OH, VA, and Washington, DC.
  • Product Description
    lnline Persuader- PedFuse Pedicle Screw System; Part Number: 11-80164
  • 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