{ "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": "95651", "product_res_number": "Z-0160-2012", "event_date_initiated": "2010-09-09", "event_date_posted": "2011-11-04", "recall_status": "Terminated", "event_date_terminated": "2011-11-21", "res_event_number": "57234", "product_code": "EKM", "product_description": "Microseal Master Cone Part Number: 815-9033\n\nMicroseal Master Cone is intended to obturate root canals during endodontic therapy procedures.", "code_info": "Lot Numbers: 111507, 082307", "firm_fei_number": "2016150", "recalling_firm": "Ormco Corporation", "address_1": "1332 S Lone Hill Ave", "city": "Glendora", "state": "CA", "postal_code": "91740", "additional_info_contact": "909-962-5600", "reason_for_recall": "The recall was initiated because SybronEndo has confirmed that the Microseal Master Cones has been mislabeled.", "root_cause_description": "Error in labeling", "action": "Sybron Dental Specialties, Inc. sent an URGENT MEDICAL DEVICE RECALL letter dated September 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to return the affected lots of product.. Products, would be replaced at no charge or credited to their account. Customers were instructed to contact SybronEndo Customer Care at 1-800-346-3636 directly to handle the arrangements of a quick return and replacement. The affected product should be returned to SybronEndo at the following address. Please label returned product \"RECALLED PRODUCT Attention: Customer Returns\"\n\nSybronEndo 1332 South Lone Hik Avenue\nGlendora, CA 91740\n\nADDITIONALLY, THEY KINDLY REQUEST CONSIGNEE COOPERATION IN COMPLETING AND FAXING BACK THE ENCLOSED ACKNOWLEDGEMENT/RETURN FORM. THIS FORM MUST BE COMPLETED AND RETURNED WHETHER OR NOT YOU HAVE ANY PRODUCT TO RETURN.\n\nCustomers were also asked to identify and recover the affected product lots listed above that may have been shipped to their customers.\n\nFor questions regarding this recall call 909-962-5600.", "product_quantity": "200 units", "distribution_pattern": "Worldwide Distribution - USA including AR, CA, FL, PA, GA, IL, TX, WA, NY, IN, AL & MT; Internationally to Canada, CIS (Commonwealth of Independent States, Israel, United Kingdom, Sweden, France, Germany, and Italy.", "openfda": { "k_number": [ "K910224", "K830115", "K896663", "K820639", "K900986", "K970134", "K023819", "K931742", "K042870", "K070246", "K863411", "K881139", "K051573", "K850863", "K823486", "K830114", "K832654", "K863638", "K915243", "K073369", "K924825", "K862129", "K971641" ], "registration_number": [ "3012627824", "3024088964", "3042283835", "2245654", "3013538161", "8010468", "3014683120", "3042866301", "3021245739", "3003418325", "3021284315", "3031582434", "3006113314", "3021023132", "1718912", "3012477813", "8020994", "3038191347", "3010598169", "3006186796", "3008590661", "3017181138", "3004133229", "2183301", "3015060193", "3009431661", "3014159752", "3044175603", "3044819802", "8040288", "3005972890", "3014326245", "3010864832", "3000303964", "3021388085", "3008370577", "3011713204", "3011434305", "3003637055", "3031191035", "3030378557", "3006621310", "3011215096", "3015272949", "3016170492", "3019741877", "3008249935", "3001082453", "3004580125", "3005176727", "3009768364", "3006550196", "3009171220", "3008887731", "8010629", "2024980", "3012996495", "9615399", "3017910185", "3043750057", "2081055", "9680845", "3006444232", "9616142", "3011276344", "3012494290", "3012421607", "3017941947", "3023443842", "9681254", "9681748", "8031010", "3014334038", "1836161", "8030637", "3008352964", "3038718579", "3045855232", "3027343382", "8010414", "8030607", "3015461866", "3017604", "3012628066", "3005558160", "3015136927", "2433629", "3007663058", "1032227", "3015526995", "3027344570", "9616128", "2320721", "3023816720", "3044150131", "3011554142", "3043648115", "3005831677", "3008857765", "3015060216", "3025436467", "2436986", "2086043", "3002957626", "3001644167", "3008388260" ], "fei_number": [ "3012627824", "3024088964", "3042283835", "2245654", "3013538161", "3014683120", "3042866301", "3021245739", "3003418325", "3021284315", "3031582434", "3006113314", "3021023132", "1718912", "3012477813", "3038191347", "3010598169", "3006186796", "3017181138", "3008590661", "3000368601", "3004133229", "2183301", "3015060193", "3009431661", "3014159752", "3044175603", "3044819802", "3003885832", "3005972890", "3014326245", "3000303964", "3021388085", "3008370577", "3002750084", "3011713204", "3011434305", "3003637055", "3002807929", "3031191035", "3030378557", "3006509795", "3006621310", "3011215096", "3015272949", "3016170492", "3019741877", "3008249935", "3010138769", "3001082453", "3004580125", "1000231788", "3005176727", "3005907356", "3000206706", "3009768364", "3006550196", "3002806577", "3009171220", "3008887731", "3012996495", "3017910185", "3043750057", "2081055", "3001421500", "3006444232", "3011276344", "3012494290", "3012421607", "3017941947", "3008875470", "3023443842", "3014334038", "1000185904", "3008352964", "3038718579", "3045855232", "3001180585", "3000719964", "3027343382", "3010862763", "3015461866", "1000554802", "3017604", "3012628066", "3005558160", "3015136927", "2433629", "3007663058", "1032227", "3015526995", "3027344570", "3023816720", "3044150131", "3011554142", "3043648115", "3005831677", "3008857765", "3015060216", "3025436467", "3002574147", "3002807826", "3002806793", "3002957626", "3001644167", "3008388260" ], "device_name": "Gutta-Percha", "medical_specialty_description": "Dental", "regulation_number": "872.3850", "device_class": "1" } } ] }