{ "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": "211309", "product_res_number": "Z-0743-2025", "event_date_initiated": "2024-11-22", "event_date_posted": "2024-12-23", "recall_status": "Open, Classified", "res_event_number": "95828", "product_code": "NXC", "k_numbers": [ "K233257" ], "product_description": "Clarity Precision Grip Attachments, for use in orthodontic treatment.\n\nPart numbers/SKUs:\n\n359-830\n359-831\n359-832\n359-833\n359-834\n359-835\n359-836\n359-837", "code_info": "Only 3M Clarity Precision Grip Attachment Dual Arch Attachments are potentially affected.\n\nPart numbers/UDI-DI:\n\n359-830/ 00652221307286;\n359-831/ 00652221307293;\n359-832/00652221307309;\n359-833/ 00652221307316;\n359-834/ 00652221307361;\n359-835/ 00652221307378;\n359-836/ 00652221307385;\n359-837/ 00652221307392", "firm_fei_number": "2110898", "recalling_firm": "3M Company - Health Care Business", "address_1": "3m Center 2510 Conway Ave 2510 3m center conway ave bldg", "city": "Saint Paul", "state": "MN", "postal_code": "55144-0001", "additional_info_contact": "Lissa Reitz\n651-733-1110", "reason_for_recall": "Attachments may not mate with the tooth as intended in the digital treatment design.", "root_cause_description": "Software design (manufacturing process)", "action": "On November 22, 2024, the firm notified customers via URGENT Product Recall letters. Customers were informed that select grip attachments were impacted by a software nonconformance, limited to the lower arch of specific dual-arch Clarity Precision Grip Attachment orders.\n\nThe firm advises that customers not use products from the identified Case IDs, and that they should dispose of affected products. Customers should complete and return the included customer product destruction form. The firm will provide replacement product.\n\nIf you have additional questions or\nneed to report an adverse event, contact the Clinician Support team (800-423-4588, option 2) or\ncustomortho@solventum.com.", "product_quantity": "171 orders", "distribution_pattern": "Product was distributed nationwide US, and internationally to Canada, Australia, and New Zealand.", "openfda": { "k_number": [ "K252931", "K251454", "K130237", "K222918", "K173785", "K182826", "K242892", "K232074", "K200908", "K981095", "K191774", "K180346", "K183159", "K200214", "K192069", "K182388", "K181747", "K223517", "K080246", "K183643", "K113618", "K212772", "K223141", "K223338", "K192767", "K222308", "K250487", "K252380", "K201450", "K221097", "K223454", "K143630", "K251758", "K250343", "K211427", "K191837", "K093821", "K192596", "K260722", "K210320", "K220287", "K241412", "K210652", "K211537", "K252870", "K192470", "K190583", "K211010", "K123925", "K203688", "K220835", "K210373", "K182329", "K180241", "K251616", "K240038", "K233152", "K073121", "K210763", "K173738", "K162609", "K212680", "K180107", "K121396", "K221537", "K123514", "K163155", "K193622", "K251415", "K223355", "K040874", "K241187", "K210540", "K181739", "K132145", "K191990", "K171860", "K220140", "K220726", "K202685", "K212660", "K221845", "K212803", "K212961", "K190003", "K191838", "K222619", "K260788", "K213297", "K222418", "K192244", "K203624", "K240501", "K192119", "K232653", "K260527", "K212496", "K231884", "K222894", "K143499", "K233544", "K183229", "K082556", "K202857", "K221475", "K241137", "K193385", "K233356", "K242929", "K163689", "K192338", "K151965", "K202792", "K200005", "K233935", "K242715", "K071970", "K190948", "K171674", "K213026", "K211510", "K081960", "K203339", "K201104", "K232887", "K191823", "K203737", "K240597", "K232233", "K211190", "K253282", "K173784", "K191308", "K210613", "K230199", "K250739", "K190394", "K172765", "K180648", "K192846", "K231464", "K193130", "K233257", "K242637", "K182658" ], "registration_number": [ "", "3004086183", "3008320092", "3030255892", "1410097", "3032027578", "3011429437", "3032452779", "3010881820", "3007031098", "3010022489", "3013508670", "3009011037", "3028340833", "3033273840", "3009482106", "3008882689", "3014701704", "3007527669", "3045923493", "3015342395", "3022727952", "3017138012", "3035484470", "3015542838", "3008475975", "3016237718", "3015272949", "3033508190", "3008910197", "1054415", "3015341209", "3044906990", "3009157552", "3015143007", "1420089", "3021024355", "1649995", "3035691085", "3005985361", "1815540", "3007130440", "9680845", "2082148", "1316408", "3013551048", "3031606517", "3032519286", "1420052", "3015595297", "3024828760", "3002706372", "3005663102", "3017619720", "3003402534", "3015302693", "3016119412", "3025029555", "3008261720", "3014680794", "3004158247", "3013950969", "3015179606", "3006430881", "3044462786", "3017220679", "3027500898", "1000486347", "3033492726", "3015674959", "3013556527", "3017155477", "3005695824", "3014749460", "3018126402", "3014054179", "1036212", "3023401336", "1032227", "3013376795", "2184045", "3025237243", "3014680924", "3015549533", "2953749", "3003622434", "3017210293", "3010730876", "1000118628", "1928237", "1937100", "3012138716", "3016998377", "3004793856", "3007060769", "2081322", "1000380364", "3044853366", "3032193293", "3042641209" ], "fei_number": [ "", "3004086183", "3008320092", "3030255892", "1410097", "3032027578", "3011429437", "3032452779", "3010881820", "3000368601", "3007031098", "3010022489", "3009011037", "3028340833", "3033273840", "3009482106", "3008882689", "3014701704", "3007527669", "3045923493", "3015342395", "3022727952", "3017138012", "3035484470", "3015542838", "3008475975", "1000128562", "3016237718", "3015272949", "3033508190", "3008910197", "3015341209", "3044906990", "3009157552", "3015143007", "1420089", "3021024355", "3035691085", "3005985361", "1815540", "3007130440", "3002519584", "2082148", "1316408", "3013551048", "3031606517", "3032519286", "1420052", "3015595297", "3024828760", "3002706372", "2024258", "3005663102", "3017619720", "3003402534", "3015302693", "3016119412", "3025029555", "3008261720", "3014680794", "3004158247", "3013950969", "3015179606", "3006430881", "3044462786", "3017220679", "3027500898", "1000486347", "3033492726", "3015674959", "3013556527", "3017155477", "3005695824", "3014749460", "3018126402", "3014054179", "3003069616", "1036212", "3023401336", "1032227", "3013376795", "3001947560", "3025237243", "3014680924", "3015549533", "3003622434", "3017210293", "3010730876", "1000118628", "1928237", "1937100", "3012138716", "3016998377", "3004793856", "3007060769", "2081322", "1000380364", "3044853366", "3032193293", "3042641209" ], "device_name": "Aligner, Sequential", "medical_specialty_description": "Dental", "regulation_number": "872.5470", "device_class": "2" } } ] }