{
  "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": [
    {
      "cfres_id": "31187",
      "product_res_number": "Z-0383-04",
      "event_date_initiated": "2003-12-02",
      "event_date_posted": "2004-07-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2009-10-05",
      "res_event_number": "28092",
      "product_code": "DZI",
      "product_description": "Products are various dental surgical drills packed in a sealed tray and labeled as sterile.  The tray is labled as follows:  3i Implant Innovations, Inc., 4555 Riverside Drive, Palm Beach 33410 USA 561-776-6700 DC500  LOT 5.0mm Implant Disposable Countersink Pilot Drill STERILE",
      "code_info": "Lot # 219630",
      "firm_fei_number": "1038806",
      "recalling_firm": "Implant Innovations, Inc.",
      "address_1": "4555 Riverside Dr",
      "city": "Palm Beach Gardens",
      "state": "FL",
      "postal_code": "33410-4200",
      "additional_info_contact": "Jacquelyn A. Hughes\n800-443-8166",
      "reason_for_recall": "The tray lid seals may be open thereby compromising the sterility barriers for the recalled lots.",
      "root_cause_description": "Other",
      "action": "The firm notified international distributors on 12/2/2003 via e-mail and also a recall notification letter was faxed to them on 12/2/2003. They were instructed to subrecall to the health professional level.  Also on 12/2/2003 all domestic accounts (health practioners) were telephoned and then faxed a recall notification letter.  Each account was instructed to check their inventory, respond back by fax and to return recalled product to Implant Innovations Inc.",
      "product_quantity": "106",
      "distribution_pattern": "Product was distributed to 45 Dentist/Surgeons nationwide in the US and also to 13 international Distributors in Canada, Sweden, Germany, Colombia, Spain, Switzerland, Australia, Japan, Austria, France, Poland, England and Greece.",
      "openfda": {
        "k_number": [
          "K113152",
          "K874535",
          "K254163",
          "K871648",
          "K032117",
          "K091331",
          "K954690",
          "K152125",
          "K990846",
          "K060270",
          "K171326",
          "K042434",
          "K803291",
          "K082649",
          "K150076",
          "K112188",
          "K192561",
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          "K080220",
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        "device_name": "Drill, Bone, Powered",
        "medical_specialty_description": "Dental",
        "regulation_number": "872.4120",
        "device_class": "2",
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