BEUDAMED
    FDA Recall 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 · Initiated August 29, 2016

    Recall

    Recall Number
    Z-0085-2017
    Event Number
    75056
    Firm
    ConMed Corporation
    FEI Number
    3001451571
    Product Code
    JOS
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    August 29, 2016
    Terminated
    June 7, 2018
    Address
    525 French Rd, Utica, NY, 13502-5945

    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.

    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].

    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