{ "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": "122646", "product_res_number": "Z-0404-2014", "event_date_initiated": "2013-10-14", "event_date_posted": "2013-11-26", "recall_status": "Terminated", "event_date_terminated": "2015-08-18", "res_event_number": "66581", "product_code": "JDS", "k_numbers": [ "K111667" ], "product_description": "Synthes 14.5 mm Outer Protection Sleeve for Suprapatellar \n\nSynthes 14.5 mm Outer Protection Sleeve for Suprapatellar is used as part of the Synthes Tibial Nail System EX to stabilize fractures of the proximal and distal tibia and the tibia shaft, open and closed tibia shaft fractures, certain pre- and post- isthmic fractures, and tibial malunions and non-unions.", "code_info": "part no. 03010.438S, lot 706802", "firm_fei_number": "3008812560", "recalling_firm": "Synthes (USA) Products LLC", "address_1": "1301 Goshen Pkwy", "city": "West Chester", "state": "PA", "postal_code": "19380-5986", "additional_info_contact": "Customer Support\n610-719-6500", "reason_for_recall": "Complaints were received reporting that a product packaged as a 14.5 mm Outer Protection Sleeve for Suprapatellar contained a 12.0 mm Outer Protection Sleeve for Suprapatellar.", "root_cause_description": "Labeling mix-ups", "action": "Synthes sent an Urgent Notice: Medical Device Recall letter dated October 14, 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 if they have any of the affected product to obtain a Return Authorization Number, complete the Verification Section at the end of the letter and return the Verification Form with the affected product to:\nCredit/Returns\nSynthes\n1101 Synthes Avenue\nMonument, CO 80132\nIf customers do not have the affected product they should complete the attached Verification Section and return all documents to Synthes by:\nFax: 866-229-7778\nScan/email: FieldAction@synthes.com\nCustomers with questions were instructed to call 610-719-5450.\nFor questions regarding this recall call 610-719-5000.", "product_quantity": "55", "distribution_pattern": "Nationwide Distribution", "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" } } ] }