Events

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
    Recall
  • Event ID
    66273
  • Event Risk Class
    Class 2
  • Event Number
    Z-0624-2014
  • Event Initiated Date
    2013-09-11
  • Event Date Posted
    2014-01-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-10-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121928
  • 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.

Device

PedFuse Bone Probe
  • Model / Serial
    Lot: 012212-001
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US Distribution: including states of: TX and VA.
  • Product Description
    PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
  • 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