Device Recall CONCEPT HEATWAVE Electrode

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.

General and Plastic Surgery Devices

2

No

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.

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.