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.
FDA Recall Z-1247-2016 · Posted 2016-03-24
Recalling FirmNeurotherm, Inc.
Recall StatusTerminated
Product CodeGXI
Date Initiated2013-02-26
Date Terminated2016-03-25
Product Quantity135 cannulas (27 boxes/5)
Reason for Recall
Straight needle labeled as a curved needle
Firm 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.
Root Cause
Process control
Distribution Pattern
US Nationwide Distribution in the states of CA ,CO, OH, OR
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.