Class II — ConMed Corporation
| Recalling firm | CONMED CORPORATION |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | Domestic: 1740; Foreign: 4770 |
| Distribution | Worldwide Distribution - US Nationwide in the states of: CA, HI, IL, IN, KS, LA, MA, NC, NM, NY, OH, OK, PA, TN, TX, UT, WA and WI; plus Foreign distribution to Australia, Canada, France, Germany, Italy, Spain, Czech Republic, Lithuania, Netherlands, Poland, Korea,Morocco, Malaysia, Mexico, Taiwan, and South Africa. |
| Initiated | 2016-08-29 |
| Classified | 2016-10-13 |
| Terminated | 2018-06-07 |
| Recall number | Z-0085-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ConMed Corporation (Z-0085-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75056/
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