{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "149207",
      "product_res_number": "Z-0085-2017",
      "event_date_initiated": "2016-08-29",
      "event_date_created": "2016-10-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-06-07",
      "res_event_number": "75056",
      "product_code": "JOS",
      "k_numbers": [
        "K991830"
      ],
      "product_description": "CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only \nProduct Usage:\nThe HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.",
      "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.",
      "firm_fei_number": "3001451571",
      "recalling_firm": "ConMed Corporation",
      "address_1": "525 French Rd",
      "city": "Utica",
      "state": "NY",
      "postal_code": "13502-5945",
      "additional_info_contact": "Ms. M. Patricia Cotter\n315-624-3533",
      "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.",
      "root_cause_description": "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.",
      "product_quantity": "Domestic: 1740; Foreign: 4770",
      "distribution_pattern": "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.",
      "openfda": {
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          "K950455",
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          "K974735",
          "K810628",
          "K952323",
          "K873654",
          "K772160",
          "K971187",
          "K792365"
        ],
        "registration_number": [
          "1721251",
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          "3014342096",
          "3002808268",
          "1017294",
          "3002806920",
          "1721194"
        ],
        "device_name": "Electrode, Electrosurgical",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4400",
        "device_class": "2"
      }
    }
  ]
}