Neurotherm, Inc. recalls Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18 Product Usage…

Recall date

February 26, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1247-2016

FDA classification

Class II

Brand / firm

Neurotherm, Inc.

Sold / distributed

US Nationwide Distribution in the states of CA ,CO, OH, OR

Why it was recalled

Straight needle labeled as a curved needle

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.