Recall Z-1247-2016— Neurotherm, Inc.

Name: FDA recall Z-1247-2016
Creator: U.S. Food and Drug Administration
Published: 2013-02-26

Class II · Terminated

Class II FDA medical device recall by Neurotherm, Inc., initiated 2013-02-26, terminated 2016-03-25. It names one FDA 510(k) clearance: K000073. 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.. Reason: Straight needle labeled as a curved needle.

Recalling firm: Neurotherm, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Terminated: 2016-03-25
Firm location: Wilmington, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K000073 — MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULAMercury Medical·cleared 2000-03-01

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

Straight needle labeled as a curved needle

Data sourced from openFDA. This site is unofficial and independent of the FDA.