{
  "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": "2026-08-27",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "150479",
      "product_res_number": "Z-0584-2017",
      "event_date_initiated": "2016-10-11",
      "event_date_posted": "2016-11-16",
      "recall_status": "Terminated",
      "event_date_terminated": "2017-07-25",
      "res_event_number": "75485",
      "product_code": "GXD",
      "k_numbers": [
        "K071482"
      ],
      "product_description": "RF MultiGen, 0406-900-000; Refurb RF MultiGen, 0406-900-000U",
      "code_info": "RF MultiGen¿, 0406-900-000, Refurb RF MultiGen¿, 0406-900-000U",
      "firm_fei_number": "1811755",
      "recalling_firm": "Stryker Instruments Div. of Stryker Corporation",
      "address_1": "4100 E Milham Ave",
      "city": "Portage",
      "state": "MI",
      "postal_code": "49002-9704",
      "additional_info_contact": "Kelly Jo Davis\n269-389-2921",
      "reason_for_recall": "Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use incorrectly contained instructions supporting the sterilization of the MultiGen cables.",
      "root_cause_description": "Labeling Change Control",
      "action": "Stryker Instruments initiated a voluntary recall of the RF MultiGen, and Refurb RF MultiGen because the instructions for use contained incorrect instructions on sterilizing the device.  Stryker distributed customer notices via certified mail on 10/11/2016. \n\nCustomer's were instructed to do the following: Immediately review this recall notification.\n2. Enclosed was a revised version of the IVS Care Instructions. Please distribute the revised version to the appropriate person or department.\n3. Remove and discard any previously distributed IVS Care Instructions or Instructions for Use.\n4. Please complete, sign, and return the enclosed Business Reply Form (BRF) acknowledging your receipt and understanding of this notification.\n5. Fax the completed BRF to Stryker Instruments Regulatory Department, 866-521-2762, or scan and email a copy to kellyjo.davis@stryker.com. Customers with questions can contact: 269 323 7700 .",
      "product_quantity": "2,675",
      "distribution_pattern": "Domestic:AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY\n\n\nForeign:France, Germany, Canada, UK, Lebanon, South Africa, Chile, Hong Kong, Poland, Argentina, Spain, Greece, Italy, India, Brazil, Switzerland, Netherlands, Sweden\n\n\nVA/DOD:",
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        "device_name": "Generator, Lesion, Radiofrequency",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4400",
        "device_class": "2"
      }
    }
  ]
}