Recall Z-1247-2016 ยท GXI Probe, Radiofrequency Lesion
Neurotherm, Inc.
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 u
| Date | Mar 24, 2016 (initiated Feb 26, 2013) |
| Status | Terminated |
| Reason | Straight needle labeled as a curved needle |
| Root cause | Process control |
| Action | NeuroTherm notified consignees by telephone between February 2- March 15, 2013 about the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return devices. |
| Quantity | 135 cannulas (27 boxes/5) |
| Distribution | US Nationwide Distribution in the states of CA ,CO, OH, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K000073 | MERCURY MEDICAL DISPOSABLE RADIOFREQUENCY CANNULA Mercury Medical, Mar 1, 2000 |