FDA Enforcement
Class II
Terminated
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.
Recall: Z-1247-2016
·
Reported March 30, 2016
Enforcement
- Recall Number
- Z-1247-2016
- Event ID
- 73407
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Neurotherm, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- March 30, 2016
- Initiation Date
- February 26, 2013
- Classification Date
- March 24, 2016
- Termination Date
- March 25, 2016
- Address
- 600 Research Dr Ste 1, N/A, Wilmington, MA, 01887-4438, United States
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
Straight needle labeled as a curved needle
Code Info
Lot number: 12131-1C
Distribution
US Nationwide Distribution in the states of CA ,CO, OH, OR
Quantity
135 cannulas (27 boxes/5)