{ "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": "113433", "product_res_number": "Z-0120-2013", "event_date_initiated": "2012-04-24", "event_date_posted": "2012-10-23", "recall_status": "Terminated", "event_date_terminated": "2012-12-12", "res_event_number": "63296", "product_code": "EJF", "product_description": "The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic bracket. Part Number \t494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039 \n\nProduct Usage:\nDamon 3MX Bicuspid Brackets are intended to be a fixed attachment on a tooth which holds an archwire during orthodontic treatment.", "code_info": "Part Number 494-4491, Description -Damon 3MX Bicuspid Bracket, Lot Number - 011265039", "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": "714-516-7400", "reason_for_recall": "The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicuspid Brackets are produced with a purple colored ID dot to identify them as maxillary bicuspid brackets; however the affected lot of product listed below was produced with dark blue colored ID dots,\nwhich identified them as maxillary central incisor brackets.", "root_cause_description": "Labeling mix-ups", "action": "Ormco/Sybronendo sent an Urgent Medical Device Recall letter via USPS 1~1 class mail, on April 24, 2012 to all consignees. Consignees were sent an updated customer notification via USPS lSI class mail on June 28, 2012. The letters identified the affected product, problem and actions to be taken. Consignees were instructed to complete the Acknowledgement/Return Form and to return any affected product in their inventory. Customers were instructed to contact Ormco Customer Care at 1-800-854-1741 to receive an RMA number. The RMA will allow for a quick return and replacement or credit.", "product_quantity": "148", "distribution_pattern": "Worldwide Distribution - US Nationwide and the countries of Canada, China, Costa Rica, Ecuador, French Polynesia, India, Kuwait, Malaysia, Philippines, Singapore, South Korea, Thailand and UAE.", "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", 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