{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "122363", "product_res_number": "Z-0407-2014", "event_date_initiated": "2013-07-30", "event_date_posted": "2013-11-27", "recall_status": "Terminated", "event_date_terminated": "2015-09-10", "res_event_number": "66419", "product_code": "JDS", "k_numbers": [ "K033071" ], "product_description": "Synthes Titanium Cannulated Humeral Nail \n\nIntended to aid in the alignment and stabilization of humeral fractures", "code_info": "Part #\t\tLot #\t \t\t\t 04.001.620S\t\t7115414\t 04.001.620S\t\t7115417\t 04.001.620S\t\t7115509\t 04.001.620S\t\t7115510\t 04.001.622S\t\t7115533\t 04.001.636S\t\t7117902\t 04.001.636S\t\t7117916\t 04.001.638S\t\t7117924\t 04.001.640S\t\t7119089\t 04.001.640S\t\t7119107\t 04.001.642S\t\t7117995\t 04.001.642S\t\t7119125\t 04.001.644S\t\t7117998\t 04.001.218S\t\t7327816\t 04.001.444S\t\t7379241\t 04.001.620s\t\t7265517", "firm_fei_number": "3005180112", "recalling_firm": "Synthes USA HQ, Inc.", "address_1": "1302 Wrights Ln E", "city": "West Chester", "state": "PA", "postal_code": "19380-3417", "additional_info_contact": "Customer Support\n610-719-5000", "reason_for_recall": "The packaging incorrectly depicts the Synthes Titanium Cannulated Humeral Nail as a 3 distal hole nail instead of a 2 distal locking hole nail.", "root_cause_description": "Pending", "action": "Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com.\nCustomers with questions were instructed to call 610-719-5450.\nFor questions regarding this recall call 610-519-5000.", "product_quantity": "14", "distribution_pattern": "Worldwide Distribution - USA (nationwide) including SC, IA, NC, TX, KY, VA, AL, PA, and Internationally to Canada.", "openfda": { "k_number": [ "K962047", "K080706", "K061783", "K021782", "K050938", "K033071", "K051557", "K832328", "K914453", "K991877", "K884406", "K983942", "K926465", "K951302", "K201336", "K141737", "K123948", "K192003", "K243608", "K061019", "K072095", "K800898", "K002325", "K230761", "K914371", "K940736", "K003212", "K014189", "K883882", "K924004", "K800142", "K770130", "K991037", "K011504", "K992348", "K062872", "K800144", "K241804", "K943855", "K040762", "K972516", "K840242", "K993004", "K111667", "K981529", "K032634", "K003215", "K240061", "K233150", "K002729", "K040212", "K000764", "K193533" ], "registration_number": [ "1834331", "3010863450", "3006513362", "3003541440", "3010009693", "1526534", "3016438694", "1720929", "3008534770", "3006846753", "1722511", "3015869121", "3010363503", "3015877656", "1822565", "1833920", "3014976005", "3013176080", "3010303097", "3011683674", "1835251", "3009116370", "3005497913", "3010041430", "3005874553", "3007366790", "3011500362", "3015869493", "3005076207", "3009417901", "1643264", "2031009", "3010220595", "1643817", "3038503932", "3014170143", "3006783837", "3036756245", "3009381600", "3000270450", "3017521423", "3016237080", "3008812560", "3006128100", "3009217531", "3043543260", "9616944", "1058584", "3009959868", "3003525643", "3015882686", "3017528621", "3025603301", "3015876273", "3003761012", "3033509898", "3009882675", "9613910", "2249615", "3010120104", "3021008900", "3004638532", "3009973505", "3010120326", "3035366890", "3013302242", "3007923096", "9615021", "1061124", "3002808145", "3008791302", "3007420745", "3014527928", "8043792", "3015399803", "3004464325", "3006017180", "2522206", "1825034", "3004369035", "3006694268", "1828288", "3016759112", "3010041499", "3007441485", "1020279", "3008868758", "3010049501", "3015946784", "3002907620", "9680825", "3007593722", "3030412764", "3015869492", "3004358587", "3015212339", "1043653", "3014279513", "3015542154", "3004142400", "3015440604", "9611390", "3007766601", "1064129", "2183449", "9611813", "3015183635", "3010057495", "1450662", "3029933740", "2029275", "3019767615", "3034676720", "3015207155", "3030714745" ], "fei_number": [ "3010863450", "3006513362", "3003541440", "3010009693", "1526534", "3016438694", "1720929", "3008534770", "3006846753", "3004574120", "3009256700", "3015869121", "1000143502", "3010363503", "3015877656", "3014976005", "3013176080", "3001049282", "3010303097", "3011683674", "3009116370", "3005497913", "1000306431", "3010041430", "3005874553", "3011500362", "3015869493", "3005076207", "1000220733", "3009417901", "1000219637", "1643264", "3002807827", "3002806685", "3010220595", "1643817", "3038503932", "3014170143", "3036756245", "3009381600", "3000270450", "3017521423", "3016237080", "3002806773", "1000512168", "3008812560", "3006128100", "3009217531", "3043543260", "3009959868", "1000306340", "3003525643", "3015882686", "3017528621", "3025603301", "3015876273", "3003761012", "3033509898", "3008647423", "3010120104", "3007282753", "3021008900", "3004638532", "3009973505", "3010120326", "3035366890", "3013302242", "3007923096", "3002808145", "3008791302", "3000205591", "3007420745", "3014527928", "3015399803", "3004464325", "1000615957", "3006017180", "2522206", "1825034", "3004369035", "3006694268", "1828288", "3016759112", "3007441485", "3001236812", "3002684506", "1020279", "3008868758", "3009322142", "3010049501", "3015946784", "3002907620", "3002808269", "3007593722", "1000115656", "3030412764", "3015869492", "3004358587", "3015212339", "1043653", "3014279513", "3015542154", "3004142400", "3015440604", "3007766601", "2183449", "3015183635", "3010057495", "1450662", "3029933740", "3019767615", "3034676720", "3015207155", "3030714745", "3003414678" ], "device_name": "Nail, Fixation, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.3030", "device_class": "2" } } ] }