FDA Device recall Z-0085-2017
CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is i…
- FDA Device
- Class II
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class II recall of CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is i… by Conmed, citing 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 co….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0085-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-29 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Conmed |
| Distribution | US |
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
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.
Identifiers
| code_info | All lots codes manufactured from 09/01/2011 through 11/17/2015: 267221, 301001, 309889, 318652, 319649, 325019, 354759…All lots codes manufactured from 09/01/2011 through 11/17/2015: 267221, 301001, 309889, 318652, 319649, 325019, 354759, 334627, 336041, 341704, 343927, 349952, 384294, 354768, 365239, 369773, 374480, 378521, 406137, 385695, 388538, 392382, 394178, 396542, 436808, 413702, 456341, 423877, 427704, 433503, 478513, 451923, 488101, 464062, 468012, 471297, 511327, 482366, 522335, 494840, 499981, 505321, 544240, 515060, 551152, 527734, 531802, 536700, 581072, 550988, 590037, 557461, 570449, 574167, 611804, 588892, 621304, 597982, 598682, 605515, 643396, 619686, 656909, 629202, 634911, 643395, 676005, 654991, 692617, 667118, 671471, 674410, 683144, 695062, 695063, 297982. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.