{ "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": 21 } }, "results": [ { "cfres_id": "76993", "product_res_number": "Z-0151-2010", "event_date_initiated": "2008-11-14", "event_date_posted": "2009-11-09", "recall_status": "Terminated", "event_date_terminated": "2012-08-09", "res_event_number": "50763", "product_code": "EKC", "k_numbers": [ "K834055" ], "product_description": "Neos Vanadium Excavator Part Number 591/0", "code_info": "Batch Numbers: 3090952, 3059925, 3059926", "firm_fei_number": "2024312", "recalling_firm": "Sybron Dental Specialties", "address_1": "1717 W Collins Ave", "city": "Orange", "state": "CA", "postal_code": "92867-5422", "additional_info_contact": "714-516-7480", "reason_for_recall": "The tips of the Neos Vanadium Excavators may prematurely release from the handle during use, and if so, the tip may be accidentally swallowed.", "root_cause_description": "Component change control", "action": "Sybron Dental wrote to the distributor by letter dated November 20, 2008 and posted Nov 24, 2008 titled \"URGENT\nMEDICAL DEVICE RECALL,\" informing them of the recall, and the reason for recall. Sybron informed the distributor to return affected batches of product. Any product in stock with the mentioned batch number was replaced at no charge or credited to their account.\n\nThe consignee was also asked to contact KerrHawe Customer Care at +41 91 610 05 05 to receive an RGA number. The affected product should be returned to KerrHawe at the following address:\n\nKerrHawe SA\nVia Strecce 4\nCH-6934 Bioggio\nSwitzerland\n\nPLEASE LABEL RETURNED PRODUCT \"RECALLED PRODUCT RETURN\". \n\nIn addition, they asked for the completed RETURN FORM to be returned by fax to +41 91 610 05 14", "product_quantity": "135", "distribution_pattern": "Worldwide distribution - Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Portugal, Spain, Switzerland, China, and the United States. One US consignee.", "openfda": { "device_name": "Excavator, Dental, Operative", "medical_specialty_description": "Dental", "regulation_number": "872.4565", "device_class": "1", "k_number": [ "K834055", "K851722" ], "registration_number": [ "", "3009340886", "8040881", "9614986", "3008797953", "1057946", "1421879", "3003334541", "3022862651", "9610612", "9611367", "1422507", "3005092287", "3005528784", "3003905396", "3029082594", "3005440795", "3010442693", "3005621335", "3004598675", "3008309654", "3011164188", "8040278", "3009703496", "3002769835", "3003407244", "3043355002", "3011499367", "5906", "3003963832", "9613083", "3010353847", "3013946322", "9616119", "3027556548", "3012101664", "3003969055", "3010288346", "2916714", "1419982", "2246990", "3005973280", "3003877407", "3001408183", "3008808049", "1416605", "3011600579", "9611899", "3021666757", "3038718579", "9610905", "8043554", "3008338766", "2511556", "3004193466", "1836161", "3003418325", "3005809810", "9680244", "3012421607", "3017352116", "3015177652", "3006059835", "2520265", "9610809", "3006410968", "3014829979", "1419247", "8010159", "3031564283", "3036795921", "9614069", "3005587147", "3019404837", "3027615", "2531684", "3008902714", "3004168759", "3014201171", "1066741", "3014257280", "1720747", "3001146947", "3011625373", "9614075", "2183301", "8010732", "3007751820", "3010055973", "3045853999", "9611503", "3043047788", "3001297506", "3010155661", "3015895045", "9680026", "3009968482", "3015512299", "9680735", "2521453", "3005831677", "3011215096", "9681622", "3005067367", "1032227", "3004992978", "3009049852", "3009513193", "9612086", "3009171220", "3002808270", "2080222", "3030644259", "3008770252", "2431166", "8041151", "3013552516", "3014937043", "3003882387", "1419489" ], "fei_number": [ "", "1000508235", "3009340886", "3008268830", "3002807373", "3008797953", "3003334541", "3022862651", "1000159990", "3005092287", "3005528784", "3003905396", "1000443015", "3002807464", "3029082594", "3005440795", "3002806575", "3010442693", "1000390051", "3005621335", "3004598675", "3008309654", "3011164188", "3009703496", "3002769835", "3003407244", "3043355002", "3011499367", "5906", "3002807169", "3003424264", "3003963832", "3013946322", "3010353847", "3027556548", "3002648735", "3012101664", "3003969055", "3003005156", "2523865", "3007803626", "3010288346", "2916714", "1000127001", "1419982", "2246990", "3005973280", "3003877407", "3001408183", "3008808049", "1416605", "3011600579", "3021666757", "3429", "3038718579", "3008338766", "1000525271", "2511556", "3004193466", "3006037906", "3003418325", "3005809810", "3012421607", "3017352116", "3002750084", "3001032747", "3015177652", "3006059835", "3002808335", "2520265", "3006410968", "3014829979", "1419247", "3031564283", "3036795921", "3005587147", "3019404837", "3008902714", "3004168759", "3014201171", "3002808360", "3001000014", "3014257280", "3546", "1720747", "3002806315", "3001146947", "3011625373", "2183301", "3007751820", "3010055973", "3045853999", "3043047788", "3001297506", "3010155661", "3015895045", "3002807935", "3009968482", "3015512299", "2521453", "3005831677", "3011215096", "3004216008", "3002291143", "1032227", "1000115048", "3004992978", "3009049852", "3009513193", "3009171220", "3002808270", "2080222", "3030644259", "3008770252", "3002681225", "3013552516", "3014937043", "3004095748", "3003882387", "1419489" ] } } ] }