{ "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": "2026-08-27", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "66566", "product_res_number": "Z-0569-2008", "event_date_initiated": "2007-10-17", "event_date_posted": "2008-01-24", "recall_status": "Terminated", "event_date_terminated": "2008-10-17", "res_event_number": "45951", "product_code": "ELZ", "product_description": "3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.", "code_info": "Lot #: P060928", "firm_fei_number": "2110898", "recalling_firm": "3M Company / Medical Division", "address_1": "3M Center, Bldg 275-05-W-06 3M Center Bldg", "city": "South St Paul", "state": "MN", "postal_code": "55144", "additional_info_contact": "651-733-1000", "reason_for_recall": "Mislabeled: Unitek Stainless Steel Permanent Molar Crowns were placed in packaging which incorrectly identified the product as Unitek Stainless Steel Primary Molar Crowns.", "root_cause_description": "Packaging process control", "action": "3M ESPE Dental Products initially contacted Distributors and Doctors on 10/22/07 through telephone calls, and sent a Device Recall letter via Fed Ex - Overnight on 10/22/07.\nThe letter informed the users that Unitek Stainless Steel Permanent Crowns Lot # P060928, Product Code 900321 may be mislabeled as Unitek Stainless Steel Primary Molar Crowns. Users were asked to stop using and/or distributing the product and contact ESPE Dental Products at 1-800-237-1650 to initiate product return and replacement.", "product_quantity": "975", "distribution_pattern": "Worldwide Distribution USA including states of TX, IN, FL, NV, KY, TN, MN, WA, NJ, PA, IL, CA, and IA, and country of CANADA.", "openfda": { "device_name": "Crown, Preformed", "medical_specialty_description": "Dental", "regulation_number": "872.3330", "device_class": "1", "registration_number": [ "3004629313", "3008081327", "3042942226", "9616103", "3013546336", "8010339", "3013410675", "3013969202", "3016564992", "3031841433", "3004158247", "3003477135", "3006316962", "3030255892", "2087481", "3004578807", "3039432369", "3042129266", "3036989911", "3007484481", "3006444232", "3043303267", "3021432364", "3038718579", "3045853414", "3006110126", "3010390478", "3042903603", "3011689956", "3021343214", "3009171220", "3016986305", "2017665", "3043226252", "3009117991", "3006226458", "2429849", "3014253211", "1060818", "3004086183", "3019944163", "8043296", "3019252621", "3014596751", "3007361893", "1424442", "3035693034", "3030680214", "3039441248", "3039641923", "3045857207", "3004193466", "9613208", "3030363302", "3029934404", "3011500388", "3003600526", "3012996495", "3031216289", "3012968498", "3002782096", "3015548849", "3031799", "3011283823", "2183301", "3012187973", "1424263", "3007353764", "3015353992", "3010326602", "3043149181", "3009312656", "3011243172", "3012502601", "3008808095", "3025604798", "2032006", "3030397241", "3042272797", "3032850585", "3003120666", "8010414", "2411797", "3026400126", "3009133627", "3017903664", "9612468", "3016998377", "3042242740", "9710613", "3006973441", "3007160911", "2437780", "3005735859", "3008155930", "1723412", "3015169722", "3013298431", "3009955691", "3026317445", "1222802", "3025769679", "3010872423", "3015531834", "3030154803", "3016506311", "3006942327", "3032163716", "3044819802", "1000123812", "8030938", "3008754429", "3009711592", "9615291", "3004721999", "3010864832", "3016127606", "3004425647", "3035335007", "9611385", "3027989276", "3006007013", "3006214249", "3009968482", "3008912871", "3012494290", "3016117382", "3020703838", "3004793856", "9710005", "3043234899", "3009390544", "3012101632", "3012421607", "3009600613" ], "fei_number": [ "3004629313", "3008081327", "3042942226", "3003053568", "3013546336", "3000246713", "3013410675", "3013969202", "3016564992", "3031841433", "3004158247", "3001236399", "3003477135", "3006316962", "3030255892", "3004578807", "3039432369", "3042129266", "3002806429", "3036989911", "3007484481", "3006444232", "3043303267", "3001746544", "3021432364", "3002811563", "3038718579", "3045853414", "3006110126", "3010390478", "3042903603", "3011689956", "3021343214", "3009171220", "3016986305", "2017665", "3043226252", "3001003585", "3009117991", "3006226458", "2429849", "3014253211", "3004086183", "3019944163", "3003029409", "1000120733", "3019252621", "3014596751", "3007361893", "3035693034", "3030680214", "3039441248", "3039641923", "1000253567", "3045857207", "3004193466", "3030363302", "3029934404", "3011500388", "3003600526", "3012996495", "3031216289", "3012968498", "3002782096", "3015548849", "3010862763", "3011283823", "2183301", "3012187973", "3007353764", "3003164550", "3000199218", "3015353992", "3010326602", "3043149181", "3009312656", "3011243172", "3012502601", "3008808095", "3025604798", "3002806930", "3030397241", "3042272797", "3032850585", "3003120666", "2411797", "3026400126", "3009133627", "3017903664", "3016998377", "3042242740", "3006973441", "3007160911", "3005735859", "3008155930", "3003015552", "3015169722", "3013298431", "3009955691", "3026317445", "3025769679", "3010872423", "3004586882", "1000592496", "3015531834", "3030154803", "3016506311", "3006942327", "3032163716", "3044819802", "1000123812", "3008754429", "3009711592", "3004721999", "3008069117", "3016127606", "3004425647", "3035335007", "3027989276", "3006007013", "3006214249", "3009968482", "3008912871", "1000207020", "3000203940", "3012494290", "3016117382", "3002807929", "3020703838", "3004793856", "3043234899", "3009390544", "3012101632", "3012421607", "3009600613" ], "k_number": [ "K912686", "K932759", "K771128", "K883325", "K770684", "K091362", "K913152", "K892893", "K931352" ] } } ] }