{ "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": 1 } }, "results": [ { "cfres_id": "113406", "product_res_number": "Z-0075-2013", "event_date_initiated": "2012-01-09", "event_date_posted": "2012-10-18", "recall_status": "Terminated", "event_date_terminated": "2014-09-16", "res_event_number": "63086", "product_code": "HBE", "k_numbers": [ "K011444", "K080802" ], "product_description": "\"***Electric Systems Foot Control with Direction Only***Rx Only***\"\n\nProduct Usage:\nCutting and shaping bone including bones of the spine and cranium.", "code_info": "Serial Numbers: E28305271001, E28305271002, E28305271003, E28305271004, E2830527100, E28305271006, E28305271007, E28305271008, E2830521009, E28305271010, E29305270901, E29305270902, E29305270903, E29305271101, E29305271102, E29305271103, E29305271104, E29305271105, E29305271106, E29305271107, E29.", "firm_fei_number": "1045834", "recalling_firm": "The Anspach Effort, Inc.", "address_1": "4500 Riverside Drive", "city": "Palm Beach Gardens", "state": "FL", "postal_code": "33410-4235", "additional_info_contact": "Aimee Hamilton\n561-627-1080", "reason_for_recall": "The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the foot control/foot pedal due to the Foot Control Cable lacking the shield connection from the cable to the connector body.", "root_cause_description": "Nonconforming Material/Component", "action": "Anspach sent an Urgent Product Removal letter dated January 9, 2012 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to contact their sales representative to facilitate the removal action by providing a replacement for the affected product. For question contact your local sales representative or the Product Support department.", "product_quantity": "41 units", "distribution_pattern": "Worldwide Distribution - US (nationwide) and the countries of: Italy, Japan, Switzerland, Turkey and Taiwan.", "openfda": { "k_number": [ "K984035", "K903664", "K162542", "K202120", "K080802", "K252060", "K172709", "K130755", "K223199", "K253627", "K905097", "K002903", "K190172", "K111520", "K121264", "K042783", "K153519", "K022942", "K232684", "K143320", "K070876", "K911819", "K143540", "K930229", "K230619", "K213208", "K943541", "K911812", "K161704", "K210377", "K182527", "K250374", "K170442", "K081475", "K203739", "K881418", "K873692", "K252662", "K250380", "K182436", "K062842", "K900388", "K072315", "K880601", "K050628", "K213072", "K014060", "K251433", "K191049", "K922299", "K191479", "K902703", "K875224", "K143399", "K032303", "K132436", "K183545", "K213454", "K935861", "K123270", "K113476", "K030172", "K250815", "K040076", "K183203" ], "registration_number": [ "3003120897", "3030733800", "3015967359", "3012494290", "1220477", "3007539489", "3012607373", "3010163695", "8030965", "3018094310", "3002807310", "1649518", "3009732568", "1450662", "9610612", "1048735", "3009380063", "2648623", "3025764223", "3016172274", "3010173425", "9681479", "3007997036", "3005282635", "8043933", "2647346", "3013557562", "3005562917", "3036773433", "3015399803", "3029300352", "1625507", "9616696", "3033509898", "1720929", "1220724", "1824199", "3006017180", "1226544", "3002807314", "1835251", "3023852420", "3015392173", "2011171", "3015151147", "1061124", "2650143", "2916714", "3015882686", "9614948", "1422375", "1833986", "1834331", "2025102", "3026776", "9680741", "3010363503", "3009417901", "3010659131", "3038472982", "3010041499", "1032347", "3021632375", "2183456", "3005706667", "3016438694", "3003800209", "3007031059", "8010516", "3010097171", "1030489", "8043792", "1836161", "1526611", "9611253", "3003418325", "3010375018", "1058584", "3008868758", "3033536319", "3009973336", "2134947", "1526534", "3003933619", "3011577940", "8010177", "3017521423", "3004464325", "3002808022", "3010155648", "3040335671", "3011300255", "3001592626", "3014725904", "3030446844", "3015453963", "3014334038", "3014479313", "2183744", "3009973505", "2246552", "3015440604", "1047843", "3017210488", "3001239363", "1825034", "3028006458", "8030607", "2029275", "1287329", "3015212339", "3005382983", "1723170", "2027754", "2133641", "9612501", "3010591625", "3005677016", "3005067367", "2648666", "3002806603", "8044015", "3008812560", "3016577622", "2953359", "3009970070", "1835444", "8031010", "8031020", "3016678045", "3025603301", "3036756245", "1319639", "1045834", "8010468", "1828288", "3014252644", "1045254", "1836357", "3006128100", "3034676720", "3030956508" ], "fei_number": [ "1000219637", "3003120897", "3001236277", "3030733800", "3015967359", "3012494290", "1220477", "3007539489", "3012607373", "3010163695", "3002807305", "3018094310", "1000139987", "3002807310", "3010938185", "3009732568", "1450662", "3000717687", "1048735", "3009380063", "2648623", "3025764223", "3016172274", "1000306431", "3003164255", "3007997036", "3005282635", "3002821504", "1000185904", "2647346", "3013557562", "1000517638", "3005562917", "3036773433", "3015399803", "3029300352", "3004536551", "1625507", "3033509898", "1720929", "1220724", "1824199", "3006017180", "3002807314", "3023852420", "1000138054", "3015392173", "1000135253", "2011171", "3015151147", "2916714", "3003755849", "3015882686", "3004169071", "3000283415", "3010363503", "3009417901", "3010659131", "3038472982", "1032347", "3021632375", "2183456", "3005706667", "3016438694", "3003800209", "3007031059", "3010097171", "1526611", "3002619595", "3004949275", "3003418325", "3010375018", "3000203466", "3008868758", "3033536319", "3008647423", "3009973336", "3002750084", "1526534", "1000139790", "3003933619", "3003495548", "3011577940", "3003064967", "3017521423", "3004464325", "3002808022", "1000306340", "3010155648", "3040335671", "3011300255", "3001592626", "3000205591", "3014725904", "3030446844", "3003128516", "3015453963", "3014334038", "1000512168", "3014479313", "2183744", "3009973505", "3546", "2246552", "3002806315", "3015440604", "3002806577", "1047843", "3005601686", "3002807830", "3017210488", "3002808269", "3001239363", "1825034", "3028006458", "1287329", "3015212339", "3005382983", "3002807687", "2027754", "3010591625", "3005677016", "2648666", "3002806603", "2648209", "3002807036", "3008812560", "3016577622", "3009970070", "3016678045", "3025603301", "3036756245", "1045834", "1828288", "1000477302", "3014252644", "3000215205", "1045254", "3006509795", "3006128100", "3034676720", "3030956508" ], "device_name": "Drills, Burrs, Trephines & Accessories (Simple, Powered)", "medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }