{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "35968",
      "product_res_number": "Z-0389-05",
      "event_date_initiated": "2004-10-27",
      "event_date_posted": "2005-01-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2005-12-20",
      "res_event_number": "30476",
      "product_code": "KCY",
      "product_description": "Zimmer™ Orthopaedic Surgical Products, Disposable Cuff, 12'' (30cm), Single Port, Single Bladder Sterile, Zimmer, Dover, OH USA. The cuff is a sterile, single use product equipped with an integral fill line. The product is packed 10 cuffs per unit",
      "code_info": "Cat #60-7075-002-00, Lot #60153745",
      "firm_fei_number": "1035617",
      "recalling_firm": "Zimmer Orthopaedic Surgical Products",
      "address_1": "2021 Old Mountain Rd",
      "city": "Statesville",
      "state": "NC",
      "postal_code": "28625-1630",
      "additional_info_contact": "Joyce Elkins\n330-364-9483",
      "reason_for_recall": "The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.",
      "root_cause_description": "Other",
      "action": "Consignees were first notified via certified mail on 10/27/2004. A follow up letter with 2 addtional lots were sent 11/11/2004.",
      "product_quantity": "42 units (10 cuffs per unit)",
      "distribution_pattern": "Nationwide, Australia, Demark, Germany",
      "openfda": {
        "k_number": [
          "K954201",
          "K840206",
          "K910512",
          "K870784",
          "K924273",
          "K925033",
          "K953953",
          "K955552",
          "K112874",
          "K780988",
          "K050411",
          "K954103",
          "K071140",
          "K880020",
          "K841558",
          "K942303",
          "K900104",
          "K162365",
          "K952038",
          "K123553",
          "K202919",
          "K945167",
          "K933994",
          "K791759",
          "K890014",
          "K813231",
          "K871982",
          "K940615",
          "K012632",
          "K842963",
          "K860095",
          "K910449",
          "K853802",
          "K860463"
        ],
        "registration_number": [
          "3014830562",
          "3010595915",
          "3008264111",
          "3005173255",
          "3031700059",
          "3006128321",
          "1058584",
          "2029275",
          "1822565",
          "3013783488",
          "3009750712",
          "3008381116",
          "9680215",
          "9681444",
          "3033511104",
          "3014313732",
          "3015495690",
          "3015542154",
          "3006950086",
          "3016445580",
          "1421307",
          "3016678045",
          "3031887985",
          "2650143",
          "1528668",
          "3006703573",
          "3007478714",
          "3004116008",
          "3023228837",
          "2011171",
          "3006975482",
          "3011277660",
          "3006535925",
          "3013846070",
          "1720929",
          "3030516433",
          "9611559",
          "9680579",
          "3011642792",
          "1048735",
          "3015309643",
          "3034520",
          "3005621729",
          "3010190204",
          "2184171",
          "3009350690",
          "3003244954",
          "1649518",
          "1018470",
          "3010291427",
          "3014023545",
          "3009605245",
          "1220351",
          "1921846",
          "3030733800",
          "3012494290",
          "3025434447",
          "3012421607",
          "3004905643",
          "3010883047",
          "1422634",
          "3004824601",
          "3007997036",
          "3002907620",
          "3014739961",
          "3032391",
          "3013730933",
          "3045058049",
          "3011683674",
          "3020163307",
          "1423537",
          "1721504",
          "1043214",
          "3004727093",
          "3015280549",
          "3010410654",
          "3011185837",
          "1650907",
          "3016950436",
          "3009039068",
          "1818910",
          "3030153385",
          "8010482",
          "1722028",
          "3009056984",
          "9613910",
          "3016965559",
          "3016764932",
          "2032098",
          "3033589330",
          "1526350",
          "3012536737",
          "8040278",
          "9611283",
          "3010759902",
          "2648666",
          "3033773618",
          "3038700849",
          "3015225571",
          "3014126909",
          "8010939",
          "3005698350",
          "3010273872",
          "3015967359",
          "2320762",
          "3010123014",
          "2528981",
          "3015207155",
          "3012276218"
        ],
        "fei_number": [
          "3014830562",
          "3010595915",
          "3008264111",
          "3005173255",
          "1000219637",
          "3031700059",
          "3006128321",
          "3001236905",
          "1000117351",
          "3013783488",
          "1000203464",
          "3003350313",
          "3009750712",
          "3008381116",
          "3003040625",
          "2648209",
          "3033511104",
          "3014313732",
          "1000514656",
          "3012599796",
          "3015495690",
          "3015542154",
          "3006950086",
          "3016445580",
          "1421307",
          "3016678045",
          "3031887985",
          "3006703573",
          "3007478714",
          "3004216008",
          "3004116008",
          "3023228837",
          "3003748933",
          "2011171",
          "3006975482",
          "3011277660",
          "3001236277",
          "3006535925",
          "3013846070",
          "1720929",
          "3030516433",
          "1000220733",
          "1000306431",
          "3011642792",
          "1048735",
          "3015309643",
          "3005621729",
          "3010190204",
          "3009350690",
          "3003244954",
          "1018470",
          "3003058448",
          "3003255513",
          "3010291427",
          "3002681132",
          "3014023545",
          "3009605245",
          "3002808440",
          "1220351",
          "1921846",
          "3030733800",
          "3012494290",
          "3025434447",
          "3012421607",
          "3004905643",
          "3004824601",
          "3001084824",
          "3007997036",
          "3002907620",
          "3014739961",
          "3013730933",
          "3045058049",
          "3011683674",
          "3020163307",
          "1721504",
          "1043214",
          "3004727093",
          "3015280549",
          "3010410654",
          "1000136409",
          "3011185837",
          "3016950436",
          "3009039068",
          "1000139815",
          "1818910",
          "3004574120",
          "3030153385",
          "3009056984",
          "1000292048",
          "3016965559",
          "1526350",
          "3016764932",
          "3033589330",
          "3012536737",
          "3010759902",
          "2648666",
          "3033773618",
          "3002299608",
          "3038700849",
          "3015225571",
          "3002806816",
          "3014126909",
          "3005698350",
          "3010273872",
          "3015967359",
          "3010123014",
          "2528981",
          "3015207155",
          "3012276218"
        ],
        "device_name": "Tourniquet, Pneumatic",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.5910",
        "device_class": "1"
      }
    }
  ]
}