{ "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": "2026-08-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191972", "product_res_number": "Z-0889-2022", "event_date_initiated": "2022-02-07", "event_date_created": "2022-04-07", "recall_status": "Terminated", "event_date_terminated": "2024-10-18", "res_event_number": "89569", "product_code": "DYJ", "product_description": "Brius Patient Specific Brackets (components in a set of custom metal orthodontic devices); BRIUS , RX Only, Non-Sterile, Custom Made Device, ID: 52345400UL", "code_info": "523758 .00nB, 523798 .00BB; 523918 .00BB; 523570 .00BB", "firm_fei_number": "3014680924", "recalling_firm": "Brius Technologies Inc.", "address_1": "2611 Westgrove Dr", "city": "Carrollton", "state": "TX", "postal_code": "75006-2349", "additional_info_contact": "Mehdi Roein Peikar\n234-564-3134", "reason_for_recall": "Pontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being documented, and released.", "root_cause_description": "Device Design", "action": "On 2/28/22, the firm, Brius Technologies Inc., sent \"URGENT: MEDICAL DEVICE RECALL\" Letters (dated 2/21/2022) with an attached Acknowledgement and Receipt Response Form (Pontics, Patient Specific Brackets , and Customized Appliances), were sent to the respective Physicians via Fed-Ex first class trackable mail; a signed acknowledgement and receipt response was requested. Actions to be taken by the customer/user include the following: At this time, it is not recommended to remove the devices and interrupt the patient's treatment. However, physicians need to monitor their patients closely for adverse events. \n\nAdditional Actions for Physicians and Patients with Pontics include in the letter:\nIt is recommended that patients with Pontics be monitored for abnormal inflammation of tissues close to the location of the Pontics in the mouth. If the inflammation is thought to be an allergic response, it is recommended the removal of the device. Another cause of inflammation could be poor oral hygiene. In this case, it is not recommended to remove the Pontic.\n\nAdditional Actions for Physicians and Patients with Patient Specific Brackets: \nAll Brackets distributed prior to market release (7/22/21) have been removed from patients. No further actions are needed at this time.\n\nAdditional Actions for Physicians and Patients with Customized Appliances: \nIt is recommended that if the TAD (Temporary Anchorage Device) used with the customized device fails during treatment, the physician should remove the customized appliance and request a replacement appliance (that will not be customized to fit TADs).\n\nIf customers have any questions they should contact: Elisabeth Miller \nemiller@primepathmedtech.com,586-242-7718\nAcknowledgment response forms should be completed and returned as follows: \nPLEASE EMAIL COMPLETED RESPONSE FORM TO: Michael.Gregory@brius.com \nOR MAIL TO: \nAttn: Michael Gregory \n2611 Westgrove Dr. Ste109 \nCarrollton, TX 75006", "product_quantity": "4", "distribution_pattern": "US Nationwide: CA, DC, MA, NJ, NY, TX", "openfda": { "k_number": [ "K912417", "K970930", "K843705", "K935154", "K925088" ], "registration_number": [ "3008005217", "3009687180", "3014054179", "9611458", "3032027578", "3036547408", "3008959450", "3012421607", "3021610873", "3005663302", "3015276158", "9680954", "3007738812", "3008524225", "3009171220", "3011539071", "3006207978", "3014683120", "3015192901", "3007603956", "3005014825", "9615291", "3038181756", "3003622434", "3008882689", "3014425175", "3043303267", "3007962015", "3030680214", "3010031846", "3012715571", "3007616048", "3013519244", "1000385618", "9681207", "3008808049", "3017138012", "1718476", "3007513373", "3015526995", "3008323540", "3004884150", "3031799", "3006707038", "3022296393", "3007010296", "9710005", "3005515228", "3016998377", "8010908", "9613079", "3043149181", "3009268271", "3013399012", "3013641573", "1524024", "3043841530", "3013561919", "3008515411", "3007320533", "3001561923", "3013946322", "3008388427", "3008475975", "3007770170", "3003850991", "3017953780", "3004645512", "3004201548", "3022315836", "3014270297", "9611514", "3009482100", "3005621362", "1000118628", "9616119", "9710113", "3007728269", "3010413926", "3018070878", "3045823938", "8044058", "3017092365", "8010874", "3004748290", "3024749697", "1121924", "3035335007", "1937100", "2081322", "3012859919", "9614977", "3002675176", "3016543896", "3010517827", "1316408", "3026326493", "2126683", "3010032042", "3002966425", "3014289665", "1815540", "2184045", "3038715999", "3004158247", "2024980", "3009955691", "3015337428", "3010669020", "3011530718", "3000286616", "3045005836", "1526352", "3034693059", "3011500388", "3005505603", "3019912897", "9680845", "3021964955", "3043648115", "8010342" ], "fei_number": [ "3008005217", "3009687180", "3014054179", "3003719498", "3032027578", "3036547408", "3008959450", "3012421607", "3021610873", "3005663302", "3015276158", "3007738812", "3008524225", "3009171220", "3011539071", "3002806467", "3006207978", "3002718942", "3014683120", "3015192901", "3007603956", "3005014825", "3038181756", "3003622434", "3008882689", "3014425175", "3003348399", "3043303267", "3007962015", "3030680214", "3010031846", "3012715571", "3007616048", "3013519244", "3001236399", "1000385618", "3008808049", "3017138012", "3002809532", "1718476", "1000128562", "3007513373", "3015526995", "3008323540", "3004884150", "3001032747", "3000368601", "3006707038", "3022296393", "3007010296", "3001682269", "3001003585", "1000293792", "3005515228", "3003164550", "3016998377", "3043149181", "3009268271", "3002807214", "3013399012", "3013641573", "1524024", "3043841530", "3013561919", "3008515411", "3007320533", "3008875470", "3001561923", "3013946322", "3008388427", "3008475975", "3007770170", "3003850991", "3017953780", "3004645512", "3004201548", "3022315836", "3014270297", "3009482100", "3005621362", "1000118628", "3005547450", "3007728269", "3002853098", "3010413926", "3018070878", "3045823938", "3017092365", "3004748290", "3024749697", "1121924", "3035335007", "1937100", "2081322", "3012859919", "3002675176", "3016543896", "3010517827", "1316408", "3026326493", "2126683", "3010032042", "3002966425", "3014289665", "1815540", "3038715999", "3004158247", "3009955691", "3015337428", "1000185289", "3010669020", "3011530718", "3000286616", "3045005836", "1526352", "3034693059", "3011500388", "3005505603", "3019912897", "3021964955", "3043648115" ], "device_name": "Retainer, Screw Expansion, Orthodontic", "medical_specialty_description": "Dental", "regulation_number": "872.5410", "device_class": "1" } } ] }