FDA Medical Device Recalls (openFDA)
ConMed Corporation: 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.
- Recall number
- Z-0085-2017
- Recalling firm
- ConMed Corporation
- 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.
- Status
- Terminated
- Initiated
- 2016-08-29
- Posted
- not on file
- Terminated
- 2018-06-07
- 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.
- Root cause
- Process change control
- Action
- Conmed sent an URGENT DEVICE RECALL letter dated August 31, 2016 and Business Reply Form were sent to the domestic consignees on August 29, 2016 via USPS First Class Mail. The letter identified the affected product, problem and actions to be taken. For questions or requests contact the Field Action Support Team at 1-800-535-8536, fax to 315-624-3225, or email largheatwv@conmed.com.
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K991830"]
- PMA numbers
- not on file
- Product code
- JOS
- Firm FEI
- 3001451571
- Firm city
- Utica
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28