Recall of PedFuse Bone Probe

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
    Orthosis, spinal pedicle fixation device - Product Code HXB
  • Reason
    Bone probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
  • Action
    On 9/13/2013, consignees were notified of the recall via email. They were asked to return the recalled product and complete and return the recall acknowledgement form via email or fax.


  • Model / Serial
    Lot: 012212-001
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US Distribution: including states of: TX and VA.
  • Product Description
    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
  • Manufacturer


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