{
  "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": "49724",
      "product_res_number": "Z-0473-2007",
      "event_date_initiated": "2006-11-28",
      "event_date_posted": "2007-01-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-05-08",
      "res_event_number": "36973",
      "product_code": "KWL",
      "product_description": "Howmedica Hip Fracture Stem System\nNo.  2 Femoral Component\nFenestrated\nSterile REF Catalogue #6942-0-020\nMade in Ireland",
      "code_info": "Hip Fracture Stem # 2: Catalog Number 6942-0-020; Lot Codes: 7237501, 7237502, 7237503, 7237505, 7600201, 7600202, 7662301, 7662302, 7662303, 7662304, 7692401, 7692402, 7692403, 7692406, 7805601, 7805602, 7805603, 7805604, 7934901, 7934902, 7944903, 7934904, 7999101, 7999102,  7999103, 7999104, 8152001, 8152002, 8152003, 8152004, 8152005, 8152006, 8152101, 8152102, 8152103, 8152104, 8241701, 8241702, 8241703, 8241704, 8241705, 8241706, 8345701, 8345702, 8345703, 8345704, 8478101, 8478102, 8478103, 8478104, 8569601, 8569602, 8632901, 8632902, 8633001, 8633101, 8633201, 8791103, 8791104, 8971301, 8993501, 8994801, 8995001, 8995601, 8995701, 9004401, 9004402, 9243601, 9243602, 9243603, 9400701, 9400702, 9400703, 9400704, 9400705, 9400706, 9475901, 9714101, 9714102, 9714104, 9911701, 9911702, 9911703, 9911705, 9911706, 9967201, 9967202, 9967203, 10353602, 10362901, 10420901, 10421001, 10585002, 10585003, 10585004, 10585005, 10585006, 10673301, 10673302, 10673303, 11064601, 11064602, 11064603, 11089903, 11089904, 11369301, 11369302, 11369303, 11436901, 11436902, 11605301, 11604302, 11791901, 11791902, 11791903, 11920901, 11920902, 11920903, 12084501,12084502, 12084503, 12084505, 12406801, 12406802, 12406803, 12406901, 12947501, 12947502, 12947503, 12947504, 13184201, 13184202,  13184203, 13184204, 13184301, 13412201, 13412202, 13412203, 13782102, 13782104, 13793501, 13973502, 13984701, 13984702, 13984703, 14108402, 14196701, 14196702, 14274601, 14368101, 14368102, 14368103, 15485101, 15485102, 15485103, 15485104, 15485105, 15668701, 15668702, 15953601, 15953602, 15953603, 15953604, 15953605, 15953606, 16059801, 16059802, 16059803, 16165601, 16203701, 16203702, 16499401, 16499402, 16499403, 16499404, 16937901, 16937902, 16937904, 17220101, 17220102, 17220103, 17220104, 17307801, 17307802, 17307804, 17658001, 17658002, 17658003, 17745201, 17745202, 17745203, 17969401, 17969402, 18320601, 18320602, 18448602, 18594101, 18594102, 18594601, 19246901, 19247001, 19247101, 19329001, 19329002, 19532501, 19532504, 19577101, 19577102,19826201, 19826203, 15953604R, 19329001R, 7805601R.",
      "firm_fei_number": "3003070421",
      "recalling_firm": "Stryker Howmedica Osteonics Corp.",
      "address_1": "325 Corporate Dr",
      "city": "Mahwah",
      "state": "NJ",
      "postal_code": "07430-2002",
      "additional_info_contact": "Larry Ross\n201-831-5972",
      "reason_for_recall": "Lack of assurance of Sterility (package integrity): Anomalies in seal width and strength that may affect the integrity of the sterile barrier.",
      "root_cause_description": "Other",
      "action": "Recall notification letters and product accountability forms were sent on 11/29 via Fed Ex with return receipt.",
      "product_quantity": "731 units",
      "distribution_pattern": "Nationwide",
      "openfda": {
        "k_number": [
          "K062408",
          "K062273",
          "K904119",
          "K905349",
          "K920231",
          "K924379",
          "K896105",
          "K965198",
          "K831420",
          "K800207",
          "K903877",
          "K173967",
          "K973614",
          "K855228",
          "K820755",
          "K821343",
          "K260536",
          "K014226",
          "K954077",
          "K101356",
          "K974807",
          "K984028",
          "K872535",
          "K990309",
          "K842465",
          "K924050",
          "K042973",
          "K844486",
          "K063791",
          "K981451",
          "K922146",
          "K926120",
          "K960538",
          "K950563",
          "K903884",
          "K872025",
          "K833599",
          "K803191",
          "K822321",
          "K252326",
          "K951355",
          "K903885",
          "K031841",
          "K844818",
          "K030972",
          "K262290",
          "K842234",
          "K842559",
          "K852584",
          "K943778",
          "K940190",
          "K811416",
          "K143184",
          "K903240",
          "K191981",
          "K872776",
          "K811738",
          "K864085",
          "K965156",
          "K905334",
          "K884889",
          "K192995",
          "K792181",
          "K844487",
          "K931752",
          "K854791",
          "K895886",
          "K830307",
          "K253675",
          "K896853",
          "K845025",
          "K874915",
          "K871656",
          "K823051",
          "K844488",
          "K884789",
          "K222632",
          "K172906",
          "K822320",
          "K111911",
          "K030205",
          "K954534",
          "K112470",
          "K841437",
          "K234028",
          "K891482",
          "K915868",
          "K853662",
          "K850928",
          "K955385",
          "K900638",
          "K931753",
          "K833403",
          "K242865",
          "K843995",
          "K852420",
          "K831851",
          "K061243",
          "K903241",
          "K984585",
          "K920193",
          "K872878",
          "K902365",
          "K992570",
          "K934353",
          "K883179",
          "K962646",
          "K071471"
        ],
        "registration_number": [
          "1020279",
          "3005551626",
          "3006406161",
          "3012392319",
          "2134285",
          "3006395932",
          "3010041693",
          "1000577893",
          "3002807315",
          "1531174",
          "1822565",
          "3030412764",
          "3010097171",
          "1828288",
          "3009973505",
          "3021566676",
          "3013055499",
          "9613350",
          "3007120646",
          "1644408",
          "3010314800",
          "3015542154",
          "2249697",
          "1828464",
          "3010178296",
          "2133928",
          "1825034",
          "3009760038",
          "3002807314",
          "8043792",
          "1835251",
          "3012329926",
          "3007923096",
          "3007913880",
          "9681642",
          "3010287737",
          "9610921",
          "1643264",
          "3009888740",
          "2648920",
          "3013186738",
          "9610726",
          "1720929",
          "3004142400",
          "3010537287",
          "1043653",
          "9681465",
          "3000236920",
          "3003061090",
          "3008812251",
          "1645151",
          "3008556682",
          "3008572101",
          "1649518",
          "3008868758",
          "1219655",
          "1833986",
          "3004748528",
          "9617083",
          "3014302784",
          "1220477",
          "3005061536",
          "3009871135",
          "3009241418",
          "3010468876",
          "1450662",
          "3005333358",
          "3011277306",
          "3012725451",
          "3004513872",
          "3008262872",
          "3003387384",
          "3020155054",
          "3004126422",
          "3009973336",
          "3012130008",
          "1038671",
          "3002808022",
          "3006809628",
          "1526534",
          "8010379",
          "3013014058",
          "3016438694",
          "3023852420",
          "3038503932",
          "3011295718",
          "1834331",
          "3002907620",
          "3011683674",
          "9616944",
          "3013302242",
          "3006801265",
          "1721676",
          "9614209",
          "1424263",
          "3004371426",
          "3009732568",
          "9616671",
          "3002807295",
          "1221763",
          "3007353762",
          "3033509898",
          "3005180920",
          "3021008900",
          "3005323511",
          "9614841",
          "3007366790",
          "2245304",
          "1836357",
          "3005913274",
          "1818910",
          "1529009",
          "9616680",
          "2249615",
          "3010057495",
          "3012275107",
          "3006356043",
          "1643817",
          "3006849754",
          "1221053",
          "9613369",
          "3010536692",
          "3004153896",
          "3014252644",
          "3004635447",
          "2246552",
          "3010898856",
          "3007740680",
          "3008110533",
          "3036756245",
          "2244478",
          "3025603301",
          "3000196378",
          "3010173425",
          "3013176080",
          "3016438761",
          "3034676720",
          "3035366890",
          "8044172",
          "3014763043",
          "3001278222",
          "3006017180",
          "1722511",
          "3003916006",
          "3002807310",
          "3015207155",
          "3015516266",
          "3006085220",
          "1833506"
        ],
        "fei_number": [
          "1020279",
          "1000118610",
          "3005551626",
          "3006406161",
          "3012392319",
          "3006395932",
          "3010041693",
          "3005233524",
          "1000577893",
          "3002807315",
          "3000717902",
          "3030412764",
          "3010097171",
          "1828288",
          "3009973505",
          "3021566676",
          "3002808293",
          "3013055499",
          "3007120646",
          "3010314800",
          "1000199976",
          "3005601732",
          "3002808402",
          "3015542154",
          "1828464",
          "1825034",
          "3002854251",
          "3009760038",
          "1000149660",
          "3003064967",
          "3002807314",
          "3012329926",
          "3002806724",
          "3002807036",
          "3007923096",
          "3007913880",
          "1000143502",
          "3010287737",
          "1000306340",
          "3000205591",
          "3002807172",
          "1000395711",
          "1643264",
          "3007282753",
          "3009888740",
          "3001236277",
          "3013186738",
          "1720929",
          "3002806534",
          "3004142400",
          "3010537287",
          "3003110073",
          "1000220733",
          "1043653",
          "3003061090",
          "1000136269",
          "3008556682",
          "3008572101",
          "3008868758",
          "1219655",
          "3004748528",
          "3014302784",
          "1220477",
          "3005061536",
          "3009871135",
          "3009241418",
          "1450662",
          "3011277306",
          "3005333358",
          "3012725451",
          "3003414678",
          "3004513872",
          "3008262872",
          "3001049282",
          "3003387384",
          "3020155054",
          "3004126422",
          "3009973336",
          "3012130008",
          "1038671",
          "3002808269",
          "3002808022",
          "1000116912",
          "3006809628",
          "1526534",
          "3002993297",
          "3013014058",
          "3016438694",
          "3023852420",
          "3038503932",
          "3011295718",
          "1832656",
          "3002907620",
          "3003386935",
          "3011683674",
          "3013302242",
          "3006801265",
          "3002287318",
          "1721676",
          "3009732568",
          "3002807295",
          "1000132037",
          "1221763",
          "3007353762",
          "3033509898",
          "3005180920",
          "3021008900",
          "3005323511",
          "2245304",
          "3002806653",
          "3005913274",
          "1818910",
          "1000086912",
          "3002807893",
          "1000139987",
          "3010057495",
          "3012275107",
          "3006356043",
          "1643817",
          "3006849754",
          "1221053",
          "3010536692",
          "3004153896",
          "3014252644",
          "3004635447",
          "2246552",
          "3010898856",
          "3007740680",
          "3008110533",
          "3036756245",
          "3003015552",
          "3025603301",
          "3000196378",
          "3002807113",
          "3013176080",
          "3016438761",
          "3034676720",
          "3035366890",
          "3003070421",
          "3002806725",
          "3014763043",
          "3001278222",
          "3002459190",
          "3006017180",
          "3003916006",
          "3002807310",
          "3015207155",
          "3015516266",
          "3006085220"
        ],
        "device_name": "Prosthesis, Hip, Hemi-, Femoral, Metal",
        "medical_specialty_description": "Orthopedic",
        "regulation_number": "888.3360",
        "device_class": "2"
      }
    }
  ]
}