{
  "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,
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  "results": [
    {
      "cfres_id": "104183",
      "product_res_number": "Z-0003-2012",
      "event_date_initiated": "2011-09-16",
      "event_date_posted": "2011-10-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-07-10",
      "res_event_number": "59979",
      "product_code": "MCM",
      "pma_numbers": [
        "P970051"
      ],
      "product_description": "Cochlear Nucleus CI512 Cochlear Implant, REF Z209051, New with Nucleus 5, Sterile EO, Made in Australia, Cochlear Ltd 14 Mars Road, Lane Cove 2066, Australia.\n\nThe cochlear implant is intended to restore a level of auditory sensation via the electrical stimulation of the auditory nerve.",
      "code_info": "Part Number Z209051 all codes.",
      "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": "Sean Bundy\n303-524-7139",
      "reason_for_recall": "Cochlear implant may shut down and cease to function.",
      "root_cause_description": "Component design/selection",
      "action": "Cochlear Americas, Inc. sent an \"URGENT MEDICAL DEVICE RECALL\" letter dated September 16, 2011 to all affected customers.  The letter describes the product, problem, and actions to be taken by the customers.  The letter instructs customers to examine their inventory and quarantine the affected product.  A recall response form was attached to the letter for customers to complete and return.  Contact Cochlear Clinic Customer Service at 877-883-3101 for questions concerning this notice.",
      "product_quantity": "33,645 units (global); 25,516 (implanted); 1,741 remaining in U.S. Market for implantation.",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and countries in Europe and Australia.",
      "openfda": {
        "device_name": "Implant, Cochlear",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "pma_number": [
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          "P830069",
          "P000015",
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          "P840024",
          "P200021",
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          "P960058",
          "P970051"
        ],
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