Neurotherm, Inc.: Medical Device Recall in 2016 - (Recall #: Z-1247-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 26, 2013

Date Posted: March 30, 2016

Recall Number: Z-1247-2016

Event ID: 73407

Reason for Recall:

Straight needle labeled as a curved needle

Status: Terminated

Product Quantity: 135 cannulas (27 boxes/5)

Code Information:

Lot number: 12131-1C

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated