Neurotherm Curved Radiofrequency — Class II medical device recall Z-1247-2016
Terminated recall by Neurotherm, Inc., reported 2016-03-30, distributed nationwide. Straight needle labeled as a curved needle
| Recall number | Z-1247-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Neurotherm, Inc., Wilmington, MA, United States |
| Recall initiated | 2013-02-26 |
| Classified | 2016-03-24 |
| Reported by FDA | 2016-03-30 |
| Terminated | 2016-03-25 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | 12131-1C |
| Model numbers | C-1010-R-18 |
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.
Reason for recall
Straight needle labeled as a curved needle
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1247-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.