{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "85634",
      "product_res_number": "Z-0119-2010",
      "event_date_initiated": "2009-09-30",
      "event_date_posted": "2009-11-02",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-12-22",
      "res_event_number": "53492",
      "product_code": "MCM",
      "pma_numbers": [
        "P970051"
      ],
      "product_description": "Nucleus Non-Magnetic Plug for removable magnet implants, REF Z50100, STERILE EO, Cochlear Limited.",
      "code_info": "Part No. Z-50100.",
      "firm_fei_number": "3005900820",
      "recalling_firm": "Cochlear Americas Inc.",
      "address_1": "13059 E Peakview Ave",
      "city": "Englewood",
      "state": "CO",
      "postal_code": "80111-6511",
      "additional_info_contact": "Deborah Arthur\n303-200-5426",
      "reason_for_recall": "Cochlear implant device component was mis-labeled.",
      "root_cause_description": "Labeling mix-ups",
      "action": "On September 28, 2009, each surgeon who received a non-magnetic plug after December 5, 2008 was sent a notification letter via courier.  The letter described the mislabeling issue and  actions for consignees. \n\nCustomers were requested to return affected product (and the quantity discarded) to the firm and review patient records to verify the implantation of the non-magnetic plug and not the mislabled product (sterile magnetic).  Direct questions about the recall by calling at 1-800-523-5798.",
      "product_quantity": "10 units",
      "distribution_pattern": "Worldwide Distribution -- United States (AL, AZ, CA, GA, IA, NC, MA, MI, MN, MO, NY, OH, OR, PA, TN, TX and WA), Brazil, and Argentina.",
      "openfda": {
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
          "P940022",
          "P830069",
          "P000015",
          "P890027",
          "P840024",
          "P200021",
          "P000025",
          "P960058",
          "P970051"
        ],
        "registration_number": [
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          "3030784382",
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}