BEUDAMED
    FDA Enforcement Class II Terminated

    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: Z-0085-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0085-2017
    Event ID
    75056
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    ConMed Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    August 29, 2016
    Classification Date
    October 13, 2016
    Termination Date
    June 7, 2018
    Address
    525 French Rd, N/A, Utica, NY, 13502-5945, United States

    Description

    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.

    Code Info

    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.

    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.

    Quantity

    Domestic: 1740; Foreign: 4770