{ "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": "36026", "product_res_number": "Z-0309-05", "event_date_initiated": "2004-11-18", "event_date_posted": "2004-12-15", "recall_status": "Terminated", "event_date_terminated": "2005-06-17", "res_event_number": "30515", "product_code": "EJF", "product_description": "Titanium Orthos Bracket", "code_info": "Part Number: 448-6111 and lot numbers:04G21, 04G83, 04J29, 04H108, 04K77. Part Number:449-6111 and lot numbers: 04G15, 04J5, 04G14, 04H141, 04H77.", "firm_fei_number": "2016150", "recalling_firm": "Ormco Corporation", "address_1": "1332 S Lone Hill Ave", "city": "Glendora", "state": "CA", "postal_code": "91740-5339", "additional_info_contact": "Wendy Urtel\n800-854-1741", "reason_for_recall": "Misassembly. Stainless steel and titanium parts were mistakenly welded together to construct the device. The weld failed.", "root_cause_description": "Other", "action": "Recall letters were mailed from 11/18 thru 11/23. Letters request return of product.", "product_quantity": "6,257", "distribution_pattern": "Nationwide and France, Luxembourg, Spain, Netherlands, Russia, Ireland, Italy, Germany, United Kingdom, Hungary, Finland, Denmark.", "openfda": { "device_name": "Bracket, Metal, Orthodontic", "medical_specialty_description": "Dental", "regulation_number": "872.5410", "device_class": "1", "k_number": [ "K801809", "K891775", "K925028", "K900578", "K923261", "K923432", "K900488", "K895483", "K930452", "K925012", "K893550", "K902050", "K892704", "K932025", "K881163", "K881789", "K933758", "K890581", "K870536", "K904089", "K893483", "K894781", "K923372", "K933080", "K771774", "K902064", "K893484", "K902390", "K903498", "K900678", "K994357", "K780170", "K844067", "K891484", "K935122", "K873649", "K891592", "K880882", "K900184", "K893654", "K920645", "K881274", "K883120", "K922499", "K890529", "K904092", "K924971", "K892419", "K936244", "K932825", "K812300", "K926427", "K902809", "K803316", "K893549", 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