{ "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": 1 } }, "results": [ { "cfres_id": "216348", "product_res_number": "Z-0228-2026", "event_date_initiated": "2025-09-26", "event_date_posted": "2025-10-21", "recall_status": "Open, Classified", "res_event_number": "97693", "product_code": "JDS", "k_numbers": [ "K201336", "K201346" ], "product_description": "LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. \n\nUsed in RFN-ADVANCEDTM Retrograde Femoral Nailing (RFNA) System and the Tibial Nail\nAdvanced System.", "code_info": "Product Code: 04.045.346TS. GTIN: 10886982301413. Lot Number: 31756P7. Expiration Date: 08/31/2025", "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": "Shannon Rook\n610-314-2088", "reason_for_recall": "Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as 42mm.", "root_cause_description": "Process control", "action": "DePuy Synthes notified consignees via email and mailed letter on 09/26/2025. Consignees were instructed to examine inventory and quarantine affected units, arrange for the return of any affected units, complete and return the Business Response Form, and place the notification in a visible area for awareness. If units were further distributed within your facility or to customers, please notify those customers and personnel.", "product_quantity": "120 units", "distribution_pattern": "Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, OH, TN, TX and the country of Canada.", "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" } } ] }