{ "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": "95383", "product_res_number": "Z-0466-2011", "event_date_initiated": "2010-10-15", "event_date_posted": "2010-11-26", "recall_status": "Terminated", "event_date_terminated": "2012-09-06", "res_event_number": "57095", "product_code": "HWX", "k_numbers": [ "K060428" ], "product_description": "CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031", "code_info": "CSS-059-70-5, Modified 7.0 mm Modified Depth Gauge, Lot 0985031", "firm_fei_number": "3000718467", "recalling_firm": "Orthohelix Surgical Designs Inc", "address_1": "1065 Medina Rd., Suite 500 1065 Medina Rd.", "address_2": "Suite 500", "city": "Medina", "state": "OH", "postal_code": "44256", "additional_info_contact": "330-869-9582", "reason_for_recall": "The print for modified CSS depth gauges has inaccurate definition of the etched screw length. The error results in a length reading that is longer (5 mm in the case of the 7.0 and 4mm in the cases of the 5.5 and 4.0) than the actual length of the buried guide wire segment and even longer (10 mm in the case of the 7.0 and 8mm in the cases of the 5.5 and 4.0) than the design intention readings. This", "root_cause_description": "Device Design", "action": "OrthoHelix issued an Important Recall Notice letter dated October 15, 2010 to their customers, identifying the affected products. Customers were requested to immediately return the afected devices. \nOrthoHelix can be contacted at 330 247-1444 concerning this recall.", "product_quantity": "2", "distribution_pattern": "Nationwide distribution: to the states of GA and MO.", "openfda": { "k_number": [ "K873067", "K840735" ], "registration_number": [ "", "1020279", "3011513267", "8010944", "3009582259", "1833824", "2134285", "3010887276", "3010370500", "3009547284", "3038195984", "3006395932", "3011623994", "8010468", "1058584", "3004049923", "3004983210", "2029275", "3011430871", "3010531060", "3010123256", "1417592", "3003120897", "1531174", "1822565", "9611827", "3014938863", "1057358", "3011024991", "3035678069", "3010097171", "3027827832", "3009141957", "1828288", "3009973505", "3003604053", "9610612", "3006846753", "3013055499", "9613350", "1720747", "1644408", "3005596514", "3009882675", "3009417901", "3009971621", "2132732", "3015869493", "3000931034", "3005739886", "3015440604", "3008114965", "3016443334", "3017565094", "1828464", "2249529", "3007289093", "1833920", "2133928", "1825034", "3019878714", "9615013", "1835572", "3026576110", "8043769", "1835251", "3015882686", "3002808227", "1835998", "3004215117", "3012234585", "9611112", "3004788213", "9615857", "1043534", "3010287737", "2133687", "3008455034", "3012447612", "3009513193", "3007993775", "9615788", "9617297", "3005031160", "1643264", "2936485", "3013156185", "3042765769", "3004638600", "3017155536", "3009888740", "8043862", "3007648354", "3013846070", "1720929", "3004187715", "3018094310", "3014554088", "3007038972", "3005575604", "3005562917", "9710629", "3011530718", "9614093", "3006513362", "3015876273", "3012478585", "3012358417", "1017294", "3009790163", "9614438", "3009165919", "3007728266", "3010047454", "3026311512", "3037407500", "3020650900", "3015383864", "3004176895", "3006563559", "3027305775", "3010667733", "3010646402", "3003244954", "8010935", "2031093", "1219655", "3010123303", "1833986", "3009051471", "3005819474", "1424434", "3014302784", "3005061536", "3013011598", "3010041511", "1224360", "1000517406", "1450662", "3006946279", "3005641619", "3008812560", "3005874553", "1054986", "3013540005", "8010099", "3019455", "1030489", "3007344102", "1421101", "3016965929", "3020584246", "3003387384", "1219518", "3010009693", "3006128100", "3012697315", "3009973336", "2183449", "3012130008", "3011015572", "3019356409", "3005827567", "9680059", "8010379", "1226544", "1221934", "3026766126", "3016438694", "3024856795", "3023852420", "3004976965", "3038503932", "1722824", "3005273623", "3009540749", "2531195", "3006215390", "3009554293", "3005677016", "1834331", "3010388970", "3017521423", "3032391", "2027467", "3003637761", "3003526896", "2031917", "3032747418", "3031240334", "9611579", "3012764194", "3008285983", "3006801265", "1836161", "1057425", "3039169546", "3004464325", "3038187464", "3011301313", "1530530", "3001239363", "3008583793", "1424263", "3030183061", "3003431869", "9610905", "3011874600", "1834379", "3009732568", "2031009", "1061124", "3013546462", "3012120772", "9616671", "9611503", "3009468807", "1649390", "3004774118", "2531477", "1221763", "3015487912", "1064129", "3000270450", "3033509898", "8010177", "3005180920", "8030607", "3035708926", "9613926", "3007366790", "8044098", "3007887127", "3015877656", "1057946", "1818910", "1836357", "3010370554", "3007125392", "1032347", "3016237080", "3007539489", "1824199", "3015831087", "3017836103", "3008650117", "3010057495", "3015399803", "3008850074", "2249615", "3006108336", "9680518", "9613910", "3002719998", "8040278", "3003139373", "3007319107", "9611283", "1835296", "3016050940", "8031020", "3010536692", "3004153896", "1935627", "2027754", "3014003062", "3012429289", "3008110533", "3036756245", "3015179588", "3007441485", "9614986", "3003477135", "1000432246", "1064017", "3010197239", "3013422236", "1649379", "3025603301", "3006460162", "3009996260", "3002949614", "3034676720", "3016032497", "2916714", "9680424", "1833053", "3009106092", "3009973844", "3013820441", "3015212339", "3011137372", "1526439", "3011061237", "2529846", "1722511", "3014314623", "3007410669", "3004549189", "1222928", "3010303097", "3005823819", "3004638532" ], "fei_number": [ "", "1020279", "3003128516", "3011513267", "3010871687", "1000514086", "3009582259", "1000219637", "3005747797", "3010887276", "3010370500", "3009547284", "3038195984", "3006395932", "3011623994", "3005233524", "3004049923", "3004983210", "3011430871", "3010531060", "3010123256", "1417592", "1000402972", "3003120897", "3000717902", "3001452082", "3000207350", "3014938863", "3011024991", "3035678069", "3010097171", "3027827832", "3009141957", "1828288", "3009973505", "3003604053", "1000221916", "3006846753", "3013055499", "1000136191", "3004028763", "1720747", "3005596514", "3015869493", "3009417901", "3009971621", "3000931034", "1000199976", "3005739886", "3015440604", "3008114965", "3016443334", "3017565094", "1828464", "3002806315", "3007289093", "3002795782", "1000518604", "3019878714", "1825034", "1000120613", "3002854251", "3026576110", "3003064967", "3015882686", "3004215117", "3002808227", "3004788213", "3012234585", "1000143502", "3002929183", "3004051158", "1043534", "3010287737", "3004216008", "1000306340", "3008455034", "3002821504", "3012447612", "3009513193", "3000205591", "3003200961", "3000206619", "3007993775", "3005031160", "3007282753", "1643264", "2936485", "3013156185", "3042765769", "1000179044", "3004638600", "3017155536", "3009888740", "3003914946", "1000208608", "3002750084", "3007648354", "3013846070", "1720929", "3004187715", "3018094310", "3014554088", "3007038972", "3005575604", "1000306276", "3005562917", "3011530718", "3002802903", "3006513362", "3015876273", "1000220733", "3001236549", "3012478585", "1000306431", "3006509795", "3012358417", "1017294", "3008782585", "3009790163", "1000477302", "1000115656", "3002807830", "3009165919", "3007728266", "3010047454", "3026311512", "3037407500", "3002904345", "3020650900", "3015383864", "3004176895", "1000114355", "3006563559", "3027305775", "3002560459", "3010667733", "3010646402", "3003244954", "3009256700", "1219655", "3010123303", "3009051471", "3005819474", "1000306303", "3014302784", "3005061536", "3013011598", "3010041511", "1450662", "1000517406", "3002806577", "3006946279", "3005641619", "3008812560", "3005874553", "3019455", "3013540005", "3007344102", "1421101", "3016965929", "3020584246", "3003387384", "1219518", "1000115331", "3010009693", "3001049282", "3006128100", "3012697315", "3009973336", "2183449", "3012130008", "3002684506", "3011015572", "1000116912", "3002806512", "3019356409", "3002807421", "3005827567", "3002993297", "1221934", "3026766126", "3016438694", "3024856795", "3023852420", "3004976965", "3038503932", "3005273623", "3002808335", "3009540749", "3005304066", "3006215390", "3002786339", "3009554293", "3010388970", "3017521423", "3000210784", "2027467", "3003637761", "3003526896", "3032747418", "3031240334", "1000306694", "3012764194", "3008285983", "3006801265", "3002287318", "3039169546", "3004464325", "3038187464", "3011301313", "3001239363", "5870", "3008583793", "3030183061", "1000512168", "3003431869", "3011874600", "3009732568", "3013546462", "3000718985", "3012120772", "3009468807", "3001236812", "3001642380", "1221763", "3015487912", "3000270450", "3033509898", "3005180920", "3035708926", "3007887127", "3003407235", "3015877656", "1818910", "3010370554", "3007125392", "3004574120", "3016237080", "1032347", "3008599177", "1000139987", "3015831087", "3008650117", "3010057495", "3015399803", "3008850074", "3017836103", "3006108336", "1824199", "3000190635", "3002719998", "3002807464", "3003139373", "3007319107", "3002806545", "3000718467", "3016050940", "3005532635", "3010536692", "3001406084", "3007539489", "3004153896", "1935627", "2027754", "3014003062", "3002299608", "3012429289", "3008110533", "3036756245", "3015179588", "3007441485", "3003854593", "3000718490", "3002806816", "3003477135", "3003015552", "1000432246", "3010197239", "3013422236", "3025603301", "3002807646", "3006460162", "3009996260", "3002949614", "1000525271", "3034676720", "3016032497", "3003424264", "2916714", "1833053", "3009106092", "3009973844", "3013820441", "3015212339", "1526439", "3011061237", "3002409980", "3014314623", "3007410669", "3005677016", "3010303097", "3004638532" ], "device_name": "Tap, Bone", "medical_specialty_description": "Orthopedic", "regulation_number": "888.4540", "device_class": "1" } } ] }