Z-0085-2017Class II

CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only

Name: Z-0085-2017 CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only
Creator: ConMed Corporation
Published: 2016-08-29
License: https://open.fda.gov/license/

ConMed Corporation / initiated 2016-08-29 / Terminated

FDA source

ConMed Corporation began a 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 intended to be used... on 2016-08-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0085-2017
Classification: Class II
Status: Terminated
Initiated: 2016-08-29
Posted: 2016-10-14
Terminated: 2018-06-07
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.
Product code: JOS Electrode, Electrosurgical
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.
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0085-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0085-2017	Class II	Terminated	Voluntary: Firm initiated	2016-10-19	2016-10-13

Product code JOS

K991830Class IICapsular Shrinkage ElectrodeLinvatec Corp. / cleared 1999-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)