{ "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": "67326", "product_res_number": "Z-0916-2008", "event_date_initiated": "2007-10-31", "event_date_posted": "2008-04-10", "recall_status": "Terminated", "event_date_terminated": "2012-03-22", "res_event_number": "46380", "product_code": "DYH", "k_numbers": [ "K061481" ], "product_description": "Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740", "code_info": "Part Number 740-0322, Lot Number 2792584", "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 Garman\n714-516-7602", "reason_for_recall": "Mislabeled: Product mislabeled with incorrect expiration date. Expiration date labeled as 2010/07 instead of 2009/07.", "root_cause_description": "Process design", "action": "Ormco sent fourteen (14) consignees Urgent Device Recall Notification via U.S. First Class mail on October 31, 2007. There were two (2) additional letters sent to the consignees in France that were translated into French. The consignees were instructed to complete the Return Form and return any affected product in their inventory. Periodic effectiveness checks will be conducted in order to follow up with non-responders. For more information, contact firm at 1-800-854-1741.", "product_quantity": "4 kits (Total US and Internationally)", "distribution_pattern": "Worldwide Distribution-USA states of IL, NY, LA, CA, NJ, NV and SC and countries of Canada, France and South Africa.", "openfda": { "k_number": [ "K894566", "K894565", "K940845", "K250015", "K955329", "K031420", "K962946", "K150128", "K890834", "K760378", "K890740", "K911286", "K952854", "K142881", "K080445", "K844134", "K875144", "K231817", "K951380", "K032195", "K952643", "K994309", "K183147", "K022224", "K880766", "K842448", "K101951", "K790962", "K033551", "K760376", "K020115", "K823409", "K884575", "K014133", "K951236", "K921385", "K953217", "K113401", "K143667", "K942742", "K093221", "K012032", "K894639", "K242537", "K981036", "K831495", "K950556", "K946255", "K952855", "K893396", "K893255", "K123348", "K100301", "K984217", "K921245", "K020502", "K950512", "K914317", "K863709", "K954244", "K853523", "K861118", "K810959", "K040375", "K032407", "K030036", "K930614", "K020648", "K921044", "K772126", "K895523", "K780028", "K871591", "K861258", "K210115", "K935714", "K854050", "K984362", "K921283", "K042422", "K823928", "K214054", "K073588", "K891464", "K142886", "K020578", "K880792", "K990743", "K161684", "K012673", "K071590", "K032042", "K014142", "K954372", "K001048", "K030644", "K954333", "K812547", "K860959", "K094006", "K843527", "K202276", "K160782", "K910803", "K874228", "K053379", "K001881", "K844133", "K935625", "K014138", "K050750", "K880790", "K914727", "K142880", "K061252", "K080724", "K832292", "K990252", "K895522", "K111696", "K880791", "K875142", "K925359", "K800392", "K192682", "K791132", "K111814", "K261129", "K880793", "K083051", "K961417", "K920781", "K911271", "K913854", "K771883", "K820092", "K061481", "K810241", "K792003", "K001446", "K081291", "K981461", "K100536", "K895521", "K952857", "K010544", "K954373", "K972890", "K072830", "K875143", "K020394", "K941015", "K875141", "K261840", "K951235", "K113197", "K014059", "K234043", "K810517", "K893037", "K951381", "K193388", "K832112", "K923399", "K040548", "K090355", "K030980", "K120619", "K771076", "K880562", "K880393", "K844844", "K904090", "K950514", "K810210", "K033703", "K883465", "K952856", "K011521", "K952858", "K030977", "K823851", "K864008", "K073697", "K173020", "K832291", "K072978", "K780334", "K810715", "K895163", "K040547", "K942727", "K954374", "K920534" ], "registration_number": [ "3045891668", "1718912", "3012421607", "3006805063", "3012187973", "1450653", "3008882689", "1000118628", "1000272892", "3010864832", "2024312", "3012494290", "8010908", "1420052", "3004109528", "3012996495", "3032763783", "3007584711", "3006697692", "3022296393", "2022039", "9680845", "3015272949", "3003622434", "3010065389", "1815540", "3008912871", "3032378317", "3004130302", "3027241817", "2023950", "3010032042", "3008524225", "3004158247", "1413475", "1721647", "3038718579", "1424442", "3013508670", "9681210", "3032163716", "3042272797", "2027375", "2511556", "3002807050", "3007210751", "3032027578", "3008005217", "2126683", "9611458", "3006113314", "1410097", "3031841433", "3044819802", "2018957", "3045857207", "2024980", "3007113445", "1718476", "3013410675", "9613953", "3014683120", "3016543896", "1215305", "9612300", "1420089" ], "fei_number": [ "3045891668", "1718912", "3012421607", "3006805063", "3012187973", "1450653", "3008882689", "1000118628", "1000272892", "2024312", "3012494290", "3002808289", "3002809532", "1420052", "3004109528", "3012996495", "3008875470", "3032763783", "3007584711", "3006697692", "3022296393", "2022039", "3015272949", "3010862763", "3003622434", "3010065389", "1815540", "3008912871", "3032378317", "3004130302", "3002807052", "3000368601", "3027241817", "2023950", "3010032042", "3008524225", "2024258", "1413475", "3004158247", "1721647", "3038718579", "3042272797", "3032163716", "2027375", "2511556", "3002807050", "3007210751", "3032027578", "3008005217", "2126683", "3006113314", "1410097", "3031841433", "3044819802", "2018957", "3045857207", "3003667632", "3007113445", "3013410675", "3014683120", "1718476", "3016543896", "1215305", "3002718942", "3002811563", "1420089" ], "device_name": "Adhesive, Bracket And Tooth Conditioner, Resin", "medical_specialty_description": "Dental", "regulation_number": "872.3750", "device_class": "2" } } ] }