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U.S. Department of Health and Human Services

Class 2 Device Recall Neurotherm

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  Class 2 Device Recall Neurotherm see related information
Date Initiated by Firm February 26, 2013
Date Posted March 24, 2016
Recall Status1 Terminated 3 on March 25, 2016
Recall Number Z-1247-2016
Recall Event ID 73407
510(K)Number K000073  
Product Classification Probe, radiofrequency lesion - Product Code GXI
Product 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.
Code Information Lot number: 12131-1C
Recalling Firm/
Manufacturer		 Neurotherm, Inc.
600 Research Dr Ste 1
Wilmington MA 01887-4438
For Additional Information Contact SAME
978-657-6519
Manufacturer Reason
for Recall		 Straight needle labeled as a curved needle
FDA Determined
Cause 2		 Process control
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.
Quantity in Commerce 135 cannulas (27 boxes/5)
Distribution US Nationwide Distribution in the states of CA ,CO, OH, OR
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = MERCURY MEDICAL
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