Events

Recall of Device Recall Neurotherm

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Neurotherm, 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
    73407
  • Event Risk Class
    Class 2
  • Event Number
    Z-1247-2016
  • Event Initiated Date
    2013-02-26
  • Event Date Posted
    2016-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144148
  • 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
    Probe, radiofrequency lesion - Product Code GXI
  • Reason
    Straight needle labeled as a curved needle.
  • Action
    NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices.

Device

Device Recall Neurotherm
  • Model / Serial
    Lot number: 12131-1C
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution in the states of CA ,CO, OH, OR
  • Product Description
    Neurotherm Curved Radiofrequency (RF) cannnula 10 cm || 18 gauge, 10 mm active tip || Model Number: C-1010-R-18 || Product Usage: || The device is a radiofrequency needle, used for the application of radiofrequency energy with as intended result, thermo coagulation of nervous tissue in the human body for pain relief. They are designed to be used to treat chronic pain. During nerve ablation, the needle is used in conjunction with a radiofrequency generator, an electrode and grounding pads.
  • Manufacturer
    Neurotherm, Inc.

Manufacturer

Neurotherm, Inc.
  • Manufacturer Address
    Neurotherm, Inc., 600 Research Dr Ste 1, Wilmington MA 01887-4438
  • Source
    USFDA