{
  "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,
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  "results": [
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      "cfres_id": "64585",
      "product_res_number": "Z-0138-2008",
      "event_date_initiated": "2007-09-04",
      "event_date_posted": "2007-12-19",
      "recall_status": "Terminated",
      "event_date_terminated": "2008-11-03",
      "res_event_number": "44953",
      "product_code": "MJO",
      "pma_numbers": [
        "P060018"
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      "product_description": "Medtronic Sofamor Danek, Prestige Cervical Disc System, Implant Trial, REF/Catalog #: 6972226, SIZE 6 X 12, MATL:  Stainless Steel/Titanium, Rx only, Manufactured at:  Bartlett, Tennessee USA",
      "code_info": "Lot Numbers:  CN07G002, CN07F006, 434150, CN06M009, CN6M016, and 506850",
      "firm_fei_number": "1000477302",
      "recalling_firm": "Medtronic Sofamor Danek USA Inc",
      "address_1": "1800 Pyramid Place",
      "city": "Memphis",
      "state": "TN",
      "postal_code": "38132-1719",
      "additional_info_contact": "Bert Kelly\n901-396-3133",
      "reason_for_recall": "Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.",
      "root_cause_description": "Device Design",
      "action": "The firm notified their consignees of the problem and the recall by Urgent Medical Device Recall letter, telephone calls and electronic mail on 09/04/2007.  Instructions include requests to immediately quarantine the product and hold for recalling firm collection.",
      "product_quantity": "196 units",
      "distribution_pattern": "Nationwide",
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        "device_name": "Prosthesis, Intervertebral Disc",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3"
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  ]
}