Z-1247-2016 Class II Terminated
FDA device recall Z-1247-2016 was initiated by Neurotherm, Inc. on February 26, 2013 and is designated Class II. Reason for recall: Straight needle labeled as a curved needle The recall status is terminated (terminated March 25, 2016). Affected quantity: 135 cannulas (27 boxes/5).
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