Z-1247-2016Class II

Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18

Name: Z-1247-2016 Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10 mm active tip Model Number: C-1010-R-18
Creator: Neurotherm, Inc.
Published: 2013-02-26
License: https://open.fda.gov/license/

Neurotherm, Inc. / initiated 2013-02-26 / Terminated / root cause: manufacturing process

FDA source

Neurotherm, Inc. began a recall of 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... on 2013-02-26. FDA classified it as Class II and gives the reason as "Straight needle labeled as a curved needle". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1247-2016
Classification: Class II
Status: Terminated
Initiated: 2013-02-26
Posted: 2016-03-24
Terminated: 2016-03-25
Recalling firm: Neurotherm, Inc.
Product: 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 code: GXI Probe, Radiofrequency Lesion
Reason for recall: Straight needle labeled as a curved needle
Root cause tag: manufacturing process
FDA 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 in commerce: 135 cannulas (27 boxes/5)
Distribution: US Nationwide Distribution in the states of CA ,CO, OH, OR
Product codes and lots: Lot number: 12131-1C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1247-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1247-2016	Class II	Terminated	Voluntary: Firm initiated	2016-03-30	2016-03-24

Product code GXI

K000073Class IIMercury Medical Disposable Radiofrequency CannulaMercury Medical / cleared 2000-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)