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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 Neurothermsee related information
Date Initiated by FirmFebruary 26, 2013
Date PostedMarch 24, 2016
Recall Status1 Terminated 3 on March 25, 2016
Recall NumberZ-1247-2016
Recall Event ID 73407
510(K)NumberK000073 
Product Classification Probe, radiofrequency lesion - Product Code GXI
ProductNeurotherm 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 ContactSAME
978-657-6519
Manufacturer Reason
for Recall		Straight needle labeled as a curved needle
FDA Determined
Cause 2		Process control
ActionNeuroTherm 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 Commerce135 cannulas (27 boxes/5)
DistributionUS Nationwide Distribution in the states of CA ,CO, OH, OR
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = GXI
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