{ "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": "86986", "product_res_number": "Z-0598-2010", "event_date_initiated": "2009-07-06", "event_date_posted": "2010-01-11", "recall_status": "Terminated", "event_date_terminated": "2010-10-25", "res_event_number": "53982", "product_code": "HBE", "k_numbers": [ "K032303", "K040300" ], "product_description": "Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.", "code_info": "All lots distributed 1/30/06 through 3/4/09. Lots 05363017, 06037017, 06069027, 06094017, 06165017, 06240017, 06275017, 06305017, 06354017, 07029017, 07079017, 07080017, 07108017, 07143017, 07219017, 07233017, 07290017, 07333017, 08021017, 08038017, 08049017, 08098017, 08155017, 08156017, 08253017, 08337017 and 09054017.", "firm_fei_number": "1811755", "recalling_firm": "Stryker Instruments Div. of Stryker Corporation", "address_1": "4100 E. Milham Ave.", "city": "Kalamazoo", "state": "MI", "postal_code": "49001", "additional_info_contact": "800-800-4236 Ext. 3808", "reason_for_recall": "The bur may fracture, resulting in fragments within the surgical site, injury to the patient or surgical team, or both.", "root_cause_description": "Device Design", "action": "Consignees were sent a letter dated 7/10/09 instructing them to locate and return product on hand for replacement. Surgeons who use the product were notified via a separate, untitled letter, dated July 13, 2009. A speed warning will be added to the product labels. Questions are directed to the firm at: \n1-800-800-4236 ext. 3808.", "product_quantity": "5438 of all products", "distribution_pattern": "Nationwide distribution: Australia, Canada, England, France, Hong Kong, Japan, Netherlands, South Africa, Sweden, Switzerland and Taiwan.", "openfda": { "k_number": [ "K903664", "K170442", "K250374", "K161704", "K213208", "K213454", "K230619", "K050628", "K182436", "K062842", "K203739", "K873692", "K902703", "K880601", "K252662", "K111520", "K162542", "K943541", "K143399", "K113476", "K153519", "K922299", "K190172", "K123270", "K202120", "K253627", "K191479", "K250815", "K223199", "K191049", "K143320", "K984035", "K252060", "K935861", "K911812", "K130755", "K900388", "K250380", "K121264", "K072315", "K143540", "K251433", "K930229", "K132436", "K881418", "K080802", "K905097", "K042783", "K183203", "K022942", "K040076", "K232684", "K183545", "K172709", "K014060", "K030172", "K911819", "K032303", "K002903", "K070876", "K210377", "K875224", "K182527", "K213072", "K081475" ], "registration_number": [ "3005382983", "3015453963", "8043933", "9681479", "3001592626", "8010468", "9611253", "1058584", "3005067367", "3036773433", "2029275", "3003120897", "3003418325", "8010516", "3014479313", "3010097171", "9610612", "8030965", "1828288", "3009973505", "1047843", "3005706667", "3009417901", "3038472982", "3011577940", "3015440604", "3011300255", "1045254", "3010659131", "1825034", "3016678045", "2648623", "2650143", "3002807314", "8043792", "1835251", "3015882686", "3010155648", "1220724", "1422375", "2011171", "9612501", "3015392173", "1720929", "3018094310", "3025764223", "3005562917", "3016172274", "3016577622", "1045834", "3003800209", "1048735", "3014725904", "8044015", "1649518", "3008868758", "1833986", "1220477", "1450662", "3008812560", "3040335671", "1030489", "3006128100", "3030956508", "3009973336", "3030733800", "3002808022", "2183456", "1526534", "1226544", "3012494290", "3017210488", "3016438694", "3023852420", "9616696", "3010363503", "3005282635", "3021632375", "3026776", "3007031059", "1834331", "3007997036", "3017521423", "1835444", "8031010", "3014334038", "1836161", "3004464325", "3001239363", "2133641", "3009970070", "2025102", "9614948", "3009732568", "3029300352", "1061124", "3013557562", "8010177", "3033509898", "8030607", "2647346", "3012607373", "1836357", "1032347", "1526611", "3007539489", "1824199", "3015399803", "3028006458", "3010163695", "3010041499", "2134947", "9680741", "3010591625", "1723170", "8031020", "2648666", "2027754", "3014252644", "2246552", "3003933619", "3036756245", "3010375018", "2183744", "3025603301", "1319639", "3010173425", "1625507", "3034676720", "2916714", "3015967359", "3030446844", "3033536319", "3002806603", "3015212339", "3006017180", "3009380063", "2953359", "3002807310", "3005677016", "3015151147" ], "fei_number": [ "3003128516", "3005382983", "3015453963", "3004169071", "1000138054", "1000219637", "3001592626", "3036773433", "3003120897", "3003418325", "3014479313", "3010097171", "1828288", "3009973505", "1000135253", "2648209", "1047843", "3005706667", "3009417901", "3038472982", "3011577940", "3015440604", "3011300255", "1045254", "3010659131", "3002806315", "1825034", "3002807687", "3016678045", "2648623", "3003064967", "3002807314", "3015882686", "3003755849", "3002807036", "3010155648", "1000306340", "1220724", "3002821504", "3000205591", "2011171", "3001236277", "3002750084", "3015392173", "1720929", "3018094310", "3025764223", "3002619595", "3005562917", "3016172274", "1000306431", "3016577622", "1045834", "3006509795", "3003800209", "3002807305", "1048735", "1000477302", "3002807830", "3000203466", "3014725904", "3004536551", "3000215205", "3008868758", "1220477", "3000283415", "3005601686", "1450662", "3002806577", "3008812560", "3040335671", "3008647423", "3006128100", "3030956508", "3009973336", "3546", "3030733800", "3002808269", "3002808022", "3003495548", "2183456", "1526534", "3004949275", "3012494290", "3017210488", "3016438694", "3023852420", "3010363503", "3005282635", "3021632375", "3007031059", "3007997036", "3017521423", "3014334038", "1000185904", "3004464325", "1000139790", "3001239363", "1000517638", "1000512168", "3009970070", "3010938185", "3003164255", "3009732568", "3029300352", "3013557562", "3033509898", "2647346", "3012607373", "1032347", "1526611", "3007539489", "1824199", "1000139987", "3015399803", "3028006458", "3010163695", "3010591625", "2648666", "2027754", "3014252644", "2246552", "3003933619", "3036756245", "3010375018", "2183744", "3025603301", "1625507", "3034676720", "2916714", "3015967359", "3030446844", "3033536319", "3002806603", "3015212339", "3006017180", "3009380063", "3002807310", "3005677016", "3000717687", "3015151147" ], "device_name": "Drills, Burrs, Trephines & Accessories (Simple, Powered)", "medical_specialty_description": "Neurology", "regulation_number": "882.4310", "device_class": "2" } } ] }