{
  "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": "2026-08-15",
    "results": {
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  "results": [
    {
      "cfres_id": "160465",
      "product_res_number": "Z-0352-2018",
      "event_date_initiated": "2017-12-06",
      "event_date_created": "2018-01-14",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-11-04",
      "res_event_number": "78790",
      "product_code": "OAR",
      "product_description": "Medtronic KYPHON(R) Express(TM) Directional Bone Filler Device, SIZE 2, REF FB, QTY 1 EA, Rx only STERILE R",
      "code_info": "UDI 00643169097254 Lot Numbers:  WI424428, WI428822, WI435227, WI439940, WI442555, WI446722, WI449819, WI455595, WI459477, WI463434, WI472175, WI472178, WI472176, WI472177, WI474575",
      "firm_fei_number": "1000477302",
      "recalling_firm": "Medtronic Sofamor Danek USA Inc",
      "address_1": "1800 Pyramid Pl",
      "city": "Memphis",
      "state": "TN",
      "postal_code": "38132-1703",
      "additional_info_contact": "Eric Epperson\n901-344-1435",
      "reason_for_recall": "Medtronic has discovered the directional arrow at the proximal end of the instrument may not correctly align with the cut out opening on the distal end of the instrument.",
      "root_cause_description": "Process control",
      "action": "Medtronic distributed a voluntary removal notice via FedEx courier service to impacted U.S. consignees on 06 DEC 2017.  The recall notice stated the following:  \n\"If he/she has not already done so, your Sales Representative will contact you to facilitate the return of any impacted products you may have in your possession. Please disseminate this information to additional personnel\nwithin your facility as appropriate, and maintain a copy of this notice in your records.\n\nInstructions to Customers:\n1.) Please locate and remove the impacted product from normal storage locations. Do not use this product.\n2.) Complete the enclosed Customer Confirmation Form and return\n3.) As applicable, contact your Medtronic Sales Representative to coordinate the return and replacement of affected product.\"",
      "product_quantity": "3,319 units",
      "distribution_pattern": "US. Austria, Belgium, Bulgaria, Canada, France, Germany, Italy, Lebanon, Luxembourg, Portugal, South Africa, US",
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        "device_name": "Injector, Vertebroplasty (Does Not Contain Cement)",
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        "regulation_number": "888.4200",
        "device_class": "1",
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