{ "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": "122719", "product_res_number": "Z-0428-2014", "event_date_initiated": "2013-06-05", "event_date_posted": "2013-11-27", "recall_status": "Terminated", "event_date_terminated": "2013-12-11", "res_event_number": "66509", "product_code": "ELZ", "product_description": "3M ESPE, Unitek Stainless Steel Permanent Molar Crowns\r\n\r\nStainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.", "code_info": "Product Code 902150 (Kit) ¿ Lot Codes N484233 and N463186 Product Code 900224 (Refill) ¿ Lot Codes N466509 and N473723", "firm_fei_number": "2110898", "recalling_firm": "3M Company - Health Care Business", "address_1": "3M Center 2510 Conway Ave , B# 275-5-W-6 2510 3m center conway ave b# 275-5-w-6", "city": "Saint Paul", "state": "MN", "postal_code": "55144", "additional_info_contact": "800-237-1650", "reason_for_recall": "3M is recalling specific lots of 3M ESPE Unitek Primary Stainless Steel Crowns - Series UR4 contain LL3 crowns which are incorrectly labeled as UR4 crowns.", "root_cause_description": "Process control", "action": "3M Company sent a Voluntary Recall letterdated June 4, 2013, to all affected consignees. The letter described the problem and the product involved in the recall. Advised consignees to review their inventory and quarantine the product and do not further distribute it. For replacement they should call Customer Service at 3M ESP Dental Products at 1-800-237-1650. If they have further distributed the product they requested they contact their customers to inform them of the recall. 3M prepared a letter to be used in their communications with their customers. The customers should contact 1-800-634-2249.\r\nFor questions regarding this recall call 651-733-5718.", "product_quantity": "1419 (1325 US, 94 OUS)", "distribution_pattern": "Worldwide Distribution - USA including IN, TX, PA, FL, NV, SC, and TN and Internationally to Canada and Saudi Arabia.", "openfda": { "device_name": "Crown, Preformed", "medical_specialty_description": "Dental", "regulation_number": "872.3330", "device_class": "1", "registration_number": [ "3015531834", "3003120666", "3042272797", "3004086183", "3006973441", "3021343214", "3030154803", "3030255892", "3008912871", "3013298431", "3025604798", "3027989276", "3005735859", "3011243172", "9615291", "3016127606", "3042129266", "3029934404", "3042903603", "2017665", "2183301", "8010339", "3026317445", "3042242740", "3044819802", "3043149181", "3008081327", "3008754429", "3004193466", "3035693034", "3010864832", "3009600613", "3039432369", "3004425647", "9616103", "3016117382", "3012187973", "3032850585", "3030363302", "3010872423", "9710005", "3043226252", "3039641923", "1424442", "3019944163", "3032163716", "1060818", "3016986305", "3013546336", "2429849", "3043303267", "3019252621", "3009171220", "3013969202", "3026400126", "2437780", "3031841433", "3012996495", "3020703838", "2087481", "3009133627", "2032006", "8043296", "3006444232", "3012494290", "3012421607", "3006226458", "3036989911", "3017903664", "3009711592", "3010326602", "3006214249", "3007484481", "3011500388", "3015169722", "9611385", "3003600526", "3006316962", "3016506311", "3006007013", "3045857207", "3004158247", "3015353992", "1424263", "3031216289", "9710613", "3038718579", "3006942327", "3014253211", "3014596751", "3042942226", "3002782096", "3006110126", "3009117991", "3011283823", "8010414", "3030397241", "3012502601", "3012101632", "3043234899", "3031799", "8030938", "9613208", "1222802", "9612468", "3007160911", "3011689956", "3008808095", "1723412", "3004629313", "3035335007", "3021432364", "3007353764", "3008155930", "3016564992", "3039441248", "3009312656", "3003477135", "3004578807", "3010390478", "2411797", "3025769679", "3013410675", "3016998377", "3004793856", "3004721999", "3012968498", "3009968482", "3009390544", "3030680214", "1000123812", "3007361893", "3015548849", "3045853414" ], "fei_number": [ "3015531834", "3003120666", "3042272797", "3004086183", "3006973441", "3021343214", "3030154803", "3030255892", "3008912871", "3013298431", "3025604798", "3027989276", "3000246713", "3005735859", "3003029409", "3011243172", "3016127606", "3042129266", "3029934404", "3042903603", "2017665", "2183301", "3026317445", "3004586882", "3042242740", "3044819802", "3002811563", "3043149181", "3008081327", "3008754429", "3004193466", "1000120733", "3035693034", "3009600613", "3039432369", "3004425647", "3001003585", "3016117382", "3002807929", "3012187973", "3032850585", "3030363302", "3010872423", "3043226252", "3002806930", "3039641923", "3019944163", "3032163716", "3016986305", "3013546336", "2429849", "3043303267", "3019252621", "3009171220", "3013969202", "3026400126", "3031841433", "3012996495", "3020703838", "1000207020", "3009133627", "1000592496", "3006444232", "3001236399", "3012494290", "3012421607", "3006226458", "3036989911", "3017903664", "3009711592", "3010326602", "3003164550", "3006214249", "3007484481", "3011500388", "3015169722", "3003600526", "3006316962", "3016506311", "3006007013", "1000253567", "3045857207", "3004158247", "3015353992", "3001746544", "3031216289", "3038718579", "3003053568", "3006942327", "3014253211", "3014596751", "3042942226", "3002782096", "3006110126", "3009117991", "3011283823", "3000199218", "3030397241", "3012502601", "3010862763", "3012101632", "3043234899", "3000203940", "3007160911", "3011689956", "3008808095", "3004629313", "3035335007", "3021432364", "3007353764", "3008155930", "3016564992", "3008069117", "3039441248", "3009312656", "3003015552", "3004578807", "3010390478", "3003477135", "2411797", "3025769679", "3013410675", "3016998377", "3004793856", "3004721999", "3012968498", "3009968482", "3009390544", "3030680214", "3002806429", "1000123812", "3007361893", "3015548849", "3045853414" ], "k_number": [ "K931352", "K912686", "K892893", "K883325", "K091362", "K913152", "K932759", "K770684", "K771128" ] } } ] }