{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 76 } }, "results": [ { "cfres_id": "122918", "product_res_number": "Z-0273-2014", "event_date_initiated": "2013-10-24", "event_date_posted": "2013-11-13", "recall_status": "Terminated", "event_date_terminated": "2014-04-10", "res_event_number": "66664", "product_code": "EBW", "k_numbers": [ "K092214" ], "product_description": "Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, and 1700471-001.\n\nDevice Name: Osseocare Pro console & Set Osseocare Pro.\nModel: 1600870-001, 1700470-001, 1700471-001.\nMarketing status: Class I, under K092214.\nDevice description: Software-based, electronically controlled tabletop device.\n\nIn dentistry for dental surgery, endodontics and implantology.", "code_info": "Model Numbers: 1600870-001, 1700470-001, 1700471-001.", "firm_fei_number": "1000125598", "recalling_firm": "Nobel Biocare Usa Llc", "address_1": "22715/22725 Savi Ranch Pkwy", "city": "Yorba Linda", "state": "CA", "postal_code": "92887", "additional_info_contact": "714-282-4800", "reason_for_recall": "The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when used with the OseeoCare Pro iPad application software release 1.2.0.7.", "root_cause_description": "Software Manufacturing/Software Deployment", "action": "Bien Air Dental send and Urgent Field Safety Notice dated October 24, 2013, to all affected customers. The letter notified customers of the recall, description of the problem, description of the product (OsseoCare Pro iPad app software release 1.2.0.7), action to be taken by user, an alternative solution, and contact details. The letter was also accompanied by an acknowlegement form. Customers with questions were instructed to call 1-800-433-2436.\nFor questions regarding this recall call 714-282-4800.", "product_quantity": "1082 (391 US)", "distribution_pattern": "Worldwide Distribution - USA (nationwide) United States and Internationally to Austria, Belgium, Brazil, Canada, Croatia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Ireland, Italy, Japan, Latvia, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Turkey, and the United Kingdom.", "openfda": { "k_number": [ "K180845", "K990954", "K230895", "K011926", "K140308", "K132570", "K163402", "K203706", "K031584", "K201192", "K090727", "K014068", "K133776", "K040153", "K220831", "K102241", "K020327", "K770129", "K002469", "K052741", "K173905", "K161957", "K141482", "K202075", "K000120", "K161213", "K181858", "K251701", "K964860", "K233117", "K123608", "K905620", "K103027", "K972924", "K213022", "K251811", "K201292", "K100785", "K092214", "K032572", "K233288", "K060287", "K090937", "K231864", "K163317", "K251407", "K041124", "K111623", "K211358", "K242646", "K163131", "K972889", "K964863", "K201191", "K083252", "K193341", "K231562", "K790322", "K103653", "K992648", "K092758" ], "device_name": "Controller, Foot, Handpiece And Cord", "medical_specialty_description": "Dental", "regulation_number": "872.4200", "device_class": "1", "registration_number": [ "3010331645", "9710363", "3007518363", "3016727307", "3007279848", "2024312", "3013576763", "3010185635", "3011824442", "3036269993", "3012477813", "3017604", "9614977", "3014004349", "2520265", "9614446", "3027339877", "3003548115", "3006540014", "3015376465", "3021226419", "3005581016", "1032227", "3010400367", "3015272949", "1422375", "3010162973", "3007958831", "3009161350", "3011300255", "3011649314", "3014953747", "3007126709", "3004082152", "3025764223", "3030126955", "3025599428", "8020776", "3017403245", "3003934980", "2320721", "9681479", "3009302876", "1054713", "8010493", "3021336182", "3009768364", "3038718579", "8044015", "3004884150", "3030091468", "3005972890", "3010097171", "3029780", "3031093388", "3013767421", "9681851", "3030926959", "3006610845", "3007345485", "3010551934", "9611253", "3014683120", "3003268570", "3015231789", "3015729", "3003637274", "3019269298", "1419489", "3007007357" ], "fei_number": [ "3010331645", "1344", "3002807009", "3007518363", "3002762033", "3016727307", "3007279848", "2024312", "3013576763", "3010185635", "1000139790", "3011824442", "3036269993", "3002807687", "3012477813", "3017604", "2520265", "3014004349", "3027339877", "3003548115", "3008981576", "3006540014", "3015376465", "3021226419", "3003755849", "1032227", "3010400367", "3005581016", "3015272949", "3011649314", "3004082152", "3007958831", "3009161350", "3011300255", "3014953747", "3030126955", "3007126709", "3003719498", "3025764223", "3025599428", "3017403245", "3002807041", "3003934980", "4224", "3009302876", "1000523896", "3021336182", "3009768364", "3038718579", "3004884150", "3030091468", "3005972890", "3010097171", "3031093388", "3013767421", "3030926959", "3004536551", "3006610845", "3007345485", "3010551934", "1000554802", "3014683120", "3003268570", "3015231789", "1000114111", "3015729", "3003637274", "3019269298", "1419489", "3007007357" ] } } ] }