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U.S. Department of Health and Human Services

Class 2 Device Recall CONCEPT HEATWAVE Electrode

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  Class 2 Device Recall CONCEPT HEATWAVE Electrode see related information
Date Initiated by Firm August 29, 2016
Create Date October 14, 2016
Recall Status1 Terminated 3 on June 07, 2018
Recall Number Z-0085-2017
Recall Event ID 75056
510(K)Number K991830  
Product Classification Electrode, electrosurgical - Product Code JOS
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.
Code Information 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.
Recalling Firm/
Manufacturer		 ConMed Corporation
525 French Rd
Utica NY 13502-5945
For Additional Information Contact Ms. M. Patricia Cotter
315-624-3533
Manufacturer 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 Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JOS and Original Applicant = LINVATEC CORP.
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