Reported Mar 30, 2016 · Terminated

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

Neurotherm, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Neurotherm, Inc. · 600 Research Dr Ste 1 · Wilmington, MA · 01887-4438

Is this the product you have?

  • Neurotherm Curved Radiofrequency (RF) cannnula 10 cm 18 gauge, 10
  • mm active tip Model NumberC-1010-R-18
  • Product UsageThe 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
Lot codes and dates
  • Lot number12131-1C
Amount recalled
135 cannulas (27 boxes/5)

Where it was sold

Why it was recalled

Straight needle labeled as a curved needle

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Mar 25, 2016 · Data as of Sep 19, 6:03 PM UTC

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