{ "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, "total": 47 } }, "results": [ { "cfres_id": "40870", "product_res_number": "Z-0012-06", "event_date_initiated": "2005-06-24", "event_date_posted": "2005-10-07", "recall_status": "Terminated", "event_date_terminated": "2006-07-03", "res_event_number": "32813", "product_code": "JDS", "k_numbers": [ "K050118" ], "product_description": "EBI Trochanteric 11mm Long Nail.", "code_info": "Catalog No./Lot Nos: 28226/164522; 28228/164523; 28230/175576; 28234/175583; 28238/175589; 28248/164527; 28324/164529; 28326/164531; 28328/164532; 28330/175614; 28332/170182; 28334/175621; 28338/175630; 28342/166415; 28344/164540; 28348/164545.", "firm_fei_number": "2242816", "recalling_firm": "EBI, L.P.", "address_1": "100 Interpace Pkwy", "city": "Parsippany", "state": "NJ", "postal_code": "07054-1149", "additional_info_contact": "Whitney Torning\n973-299-9300 Ext. 3964", "reason_for_recall": "Upon evaluation, the firm found that the fatigue strength of these nails was below the required value as specified in the design specification.", "root_cause_description": "Other", "action": "The firm sent out via e-mail notification to their field representatives on 6/27/2005 to identify, remove and return to EBI all affected product from their inventories. One direct customer, Dr. Maylack was sent a recall letter on 7/7/2005.", "product_quantity": "102 nails", "distribution_pattern": "There are 9 sales representatives that are instructed to remove and return the EBI nail from nationwide customers.", "openfda": { "k_number": [ "K940736", "K003212", "K061783", "K951302", "K011504", "K003215", "K040212", "K061019", "K201336", "K992348", "K243608", "K032634", "K884406", "K192003", "K000764", "K230761", "K072095", "K021782", "K241804", "K040762", "K832328", "K962047", "K981529", "K800142", "K983942", "K914371", "K002729", "K050938", "K051557", "K883882", "K926465", "K062872", "K080706", "K033071", "K943855", "K800898", "K991877", "K193533", "K800144", "K993004", "K014189", "K141737", "K972516", "K770130", "K123948", "K991037", "K002325", "K233150", "K840242", "K914453", "K240061", "K924004", "K111667" ], "registration_number": [ "3017528621", "3009381600", "3015542154", "3004369035", "1450662", "3007420745", "3015869493", "3014527928", "2031009", "9613910", "9680825", "3010303097", "3002808145", "3015946784", "3008791302", "3043543260", "9615021", "3015399803", "3014976005", "3002907620", "3006513362", "3007593722", "3033509898", "3006846753", "1720929", "3006017180", "3015877656", "1835251", "3011683674", "1722511", "3010049501", "9611390", "1061124", "3015882686", "3015207155", "1834331", "3007441485", "3010363503", "3009882675", "3009417901", "3010041499", "3010009693", "1043653", "9611813", "3016438694", "3021008900", "3030412764", "8043792", "3009217531", "3005497913", "1064129", "1058584", "3008868758", "3003761012", "1526534", "3013176080", "3017521423", "3004464325", "3010057495", "3015183635", "1833920", "3015869121", "1643817", "3003525643", "3011500362", "3004638532", "3010220595", "1822565", "3009973505", "3015876273", "3009959868", "3015440604", "3007766601", "3013302242", "3010041430", "3015869492", "3019767615", "3029933740", "3006783837", "3010120326", "3034676720", "1825034", "3009116370", "3038503932", "3006694268", "2029275", "3014170143", "3005076207", "3004358587", "3015212339", "3014279513", "3008534770", "3000270450", "1020279", "3007366790", "3010120104", "9616944", "2249615", "3003541440", "3004142400", "3005874553", "3008812560", "3010863450", "3025603301", "3036756245", "3007923096", "1828288", "3016759112", "3016237080", "1643264", "3030714745", "3035366890", "2522206", "3006128100", "2183449" ], "fei_number": [ "1000219637", "3017528621", "3009381600", "3007282753", "3015542154", "3002807827", "3004369035", "1450662", "3007420745", "3015869493", "1000220733", "3014527928", "1000306431", "3002806685", "3010303097", "3002808145", "3015946784", "3008791302", "3043543260", "3015399803", "3014976005", "3002907620", "3006513362", "3007593722", "3002806773", "3033509898", "3006846753", "1720929", "3006017180", "3015877656", "3011683674", "3010049501", "3015882686", "3015207155", "3009322142", "3004574120", "3007441485", "3010363503", "3009417901", "3010009693", "1043653", "3016438694", "3021008900", "3030412764", "3009217531", "3005497913", "3001049282", "3008868758", "3009256700", "3008647423", "1000615957", "3003761012", "1526534", "1000143502", "3013176080", "3017521423", "3004464325", "3010057495", "3015183635", "1000306340", "3001236812", "3015869121", "1643817", "3000205591", "3003525643", "3011500362", "3004638532", "1000512168", "3010220595", "3009973505", "3015876273", "3009959868", "3015440604", "3007766601", "3013302242", "3010041430", "3002684506", "1000115656", "3015869492", "3019767615", "3002808269", "3029933740", "3010120326", "3034676720", "1825034", "3009116370", "3038503932", "3006694268", "3014170143", "3005076207", "3004358587", "3015212339", "3014279513", "3008534770", "3000270450", "1020279", "3003414678", "3010120104", "3003541440", "3004142400", "3005874553", "3008812560", "3010863450", "3025603301", "3036756245", "3007923096", "1828288", "3016759112", "3016237080", "1643264", "3030714745", "3035366890", "2522206", "3006128100", "2183449" ], "device_name": "Nail, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2" } } ] }