Z-1247-2016 Class II Terminated

Recalled by Neurotherm, Inc. — Wilmington, MA

Recall Details

Product Type
Devices
Report Date
March 30, 2016
Initiation Date
February 26, 2013
Termination Date
March 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
135 cannulas (27 boxes/5)

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

Distribution Pattern

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

Code Information

Lot number: 12131-1C