{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
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  "results": [
    {
      "cfres_id": "87002",
      "product_res_number": "Z-0546-2010",
      "event_date_initiated": "2009-11-30",
      "event_date_posted": "2009-12-17",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-05-12",
      "res_event_number": "53996",
      "product_code": "HBB",
      "k_numbers": [
        "K020069"
      ],
      "product_description": "Medtronic Midas Rex Legend Footed Attachment, AF01.\n\nIntended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications.",
      "code_info": "Serial Numbers:  A3275-03, A7094-01, B1536-06, B1536-07, B3532-02, B8465-09, C3472-08, C7120-02, C7255-01, D1646-02, D1972-01, D1972-04, D2604-01, D2604-04, D4212-05, D5683-03, D6441-01, D6504-05, P00197407, P00204906, P00360920 - P00360924, P00363252 - P00363256, P00364049 - P00364052, P00365059 - P00365061, P00365786 - P00365792, P00365794, P00365799, P00365800, P00368100 - P00368103, P00369724 - P00369726, P00369728, P00372167 - P00372171, T-1035-07, T2648-02, T3188-06 and T5016-02.",
      "firm_fei_number": "1625507",
      "recalling_firm": "Medtronic Sofamor Danek Usa, Inc - Dallas Distribution",
      "address_1": "4620 N Beach St",
      "city": "Fort Worth",
      "state": "TX",
      "postal_code": "76137-3219",
      "additional_info_contact": "817-831-4181",
      "reason_for_recall": "Component of product attachment may be outside established tolerance with potential for footed portion to break during normal use.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "Medtronic issued an \"Urgent: Medical Device Recall\" letter dated November 30, 2009.  Consignees were notified of the issued and asked to quarantine any affected product and return affected product to the firm for replacement.\n\nFor further information, contact Medtronic Powered Surgical Solutions Customer Service at 1-800-433-7080 or 1-817-788-6400.",
      "product_quantity": "64",
      "distribution_pattern": "Worldwide Distribution -- Including the United States (DC, TN, NC, KY, AL, FL, NJ, OH, MI, IN, NY, WA, CA, NV, NM, IA, MO, NE and UT), Great Britain, Brazil, Turkey, Singapore and the Netherlands.",
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        "device_name": "Motor, Drill, Pneumatic",
        "medical_specialty_description": "Neurology",
        "regulation_number": "882.4370",
        "device_class": "2"
      }
    }
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}