{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
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  },
  "results": [
    {
      "cfres_id": "70464",
      "product_res_number": "Z-0397-2009",
      "event_date_initiated": "2008-02-21",
      "event_date_posted": "2009-01-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-01-15",
      "res_event_number": "47848",
      "product_code": "GET",
      "product_description": "ConMed Linvatec  Hall Surgical Blades, Sterile ST SAG BLADE, Catalog # 00502314400, 00502313900, 00502314100, 00502311800,\n00502313800, 00502314000, and 00502312800.\n\n\nConMed Linvatec Hall (R) Surgical Blades are intended for use in small bone or large bone orthopedic surgeries.  These blades are designed to cut bone in an oscillating plane.",
      "code_info": "BBD23466, BBD29778, BBD29779, BBD31414, BBD31966, BBD34684, BBD23581, BBD26613, BBD28001, BBD29406, BBD31980, BBD21938, BBD23046 through BBD23050, BBD23828, BBD24448, BBD24633, BBD24634, BBD24635, BBD24636, BBD25062, BBD25063, BBD25066 through BBD25071, BBD25075, BBD25342 through BBD25344, BBD25448, BBD25345 through BBD25348, BBD28220, BBD28221, BBD29967 through BBD29971, BBD31755 through BBD31758, BBD32191, BBD33986 through BBD33989, BBD33991 through BBD33994, BBD33996, BBD33997, BBD34284, BBD34285, BBD35203, BBD35406, BBD35407, BBD35715, BBD36138, BBD36140, BBD36454, BBD36455, BBD36861, BBD36862 through BBD36864, BBD37677, BBD42014, BBD21968, BBD23826, BBD26026, BBD26276, BBD30509, BBD31759, BBD34787, BBD35411, BBD39000, BBD21955, BBD23038, BBD24444, BBD27210, BBD32799, BBD33034, BBD40973, BBD23464, BBD27209, BBD29395, BBD37661, BBD37683, BBD39764, BBD21966, BBD23039, BBD23825, BBD30501, BBD30503, BBD31752, BBD33985, BBD34279, BBD35200, BBD35713, BBD36137, BBD36458, and BBD40975.",
      "firm_fei_number": "1017294",
      "recalling_firm": "Linvatec Corp.",
      "address_1": "11311 Concept Boulevard",
      "city": "Largo",
      "state": "FL",
      "postal_code": "33773",
      "additional_info_contact": "727-392-6464",
      "reason_for_recall": "Sterility compromised.  There is a possibility that certain catalog number and lots of ConMed Linvatec Hall Surgical Blades, may have a hole(s) in the corner(s) of the blister package(tray), thereby potentially compromising the sterility of the devices.",
      "root_cause_description": "Process control",
      "action": "An Urgent Medical Device Recall letter was issued.  Customers must check their facility's inventory immediately for the catalog and lot numbers in the attached list.  They also need to complete and sign the enclosed Reply Form and mail or fax the Reply Form to ConMed Linvatec using the enclosed self addressed postage paid envelope or fax 727-319-5701.  Customers have an option to either re-sterilize the products using the re-sterilization instructions in the letter or they can return the devices to ConMed Linvatec for a credit using the enclosed preprinted FedEx Air Bill with ConMed Linvatec's Bill Number and the return goods number.  Recall is being conducted to the distributor and end user level.",
      "product_quantity": "30403",
      "distribution_pattern": "Worldwide Distribution",
      "openfda": {
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          "K953432",
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          "K953433",
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          "K833187",
          "K954076",
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        "registration_number": [
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        "fei_number": [
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          "3009599228",
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        ],
        "device_name": "Motor, Surgical Instrument, Pneumatic Powered",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4820",
        "device_class": "1"
      }
    }
  ]
}