{ "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": "141617", "product_res_number": "Z-0343-2016", "event_date_initiated": "2015-11-04", "event_date_posted": "2015-11-30", "recall_status": "Terminated", "event_date_terminated": "2016-01-19", "res_event_number": "72590", "product_code": "DZC", "product_description": "Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part No. 211-0952. Intended to provide tooth movement.", "code_info": "Lot No. 21538339", "firm_fei_number": "2016150", "recalling_firm": "Ormco/Sybronendo", "address_1": "1332 S Lone Hill Ave", "city": "Glendora", "state": "CA", "postal_code": "91740-5339", "additional_info_contact": "909-962-5600", "reason_for_recall": "Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation temperature as listed on the labeling is incorrect.", "root_cause_description": "Employee error", "action": "A recall letter dated 11/5/15 was sent to all their customers who purchased the Copper NiTi Preformed Archwires because it has been brought to Ormco's attention that the product transformation temperature as listed on the labeling is incorrect. The wire is labeled as having 40 degrees Celsius transformation temperature, but the actual wire has a transformation temperature of 29 degrees Celsius. The letter provides the customers with the problems identified and the actions to be taken. Customers are instructed to complete and fax back the enclosed acknowledgement form.", "product_quantity": "161 units", "distribution_pattern": "Distributed US (nationwide) and the countries of Canada, Japan, Mexico, Russia, and Peru.", "openfda": { "device_name": "Wire, Orthodontic", "medical_specialty_description": "Dental", "regulation_number": "872.5410", "device_class": "1", "k_number": [ "K923836", "K923837", "K843722", "K924805", "K923839", "K943334", "K923838", "K812454", "K920905", "K843171", "K833788", "K863742", "K852975", "K931631", "K933377", "K930202", "K851055", "K933378", "K935140", "K841638", "K851878", "K112640", "K933376", "K933374", "K935142", "K934265", "K935638", "K933379", "K933380", "K920850" ], "registration_number": [ "", "3038187461", "3016543896", "3015136927", "3015060193", "3015259864", "3034603709", "8010874", "3006155566", "3007962015", "3022296393", "3031191035", "3009402818", "3013689189", "3004730002", "3003850991", "3013508670", "3004645512", 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