CONCEPT HEATWAVE Electrode 130 mm x 2 — Class II medical device recall Z-0085-2017
Terminated recall by ConMed Corporation, reported 2016-10-19, distributed nationwide. CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn mar
| Recall number | Z-0085-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ConMed Corporation, Utica, NY, United States |
| Recall initiated | 2016-08-29 |
| Classified | 2016-10-13 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2018-06-07 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CZ, DE, ES, FR, IT, KR, LT, MA, MX, MY, NL, PL, TW, ZA |
| Model numbers | CS-023 |
Product
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.
Reason for recall
CONMED received complaints of damage to the CS-023 electrodes shaft insulation which could result in burn marks on the shaft. If the shaft insulation is damaged in any way, it could increase the risk of patient burn.
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-0085-2017. 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.