All Medical Device Recalls

Detailed Result for Z-2204-2010

CFRES ID:	92213
Device Name:	N/A
Product RES Number:	Z-2204-2010
Event Date Initiated:	2010-04-20
Event Date Posted:	2010-08-10
Event Date Created:	N/A
Event Date Terminated:	2011-01-19
Recall Status:	Terminated
Res Event Number:	55909
Product Code:	JWH
K Numbers:	["K023546"]
PMA Numbers:	N/A
Product Description:	Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
Code Info:	M402080.
Recalling Firm:	Biomet, Inc.
Firm FEI Number:	N/A
Adress 1:	56 E Bell Dr
Adress 2:	N/A
City:	Warsaw
State:	IN
Postal Code:	46582
Additional Contact Info:	574-267-6639 Ext. 1676
Reason for Recall:	A knee implant labeled as left was opened and the package actually contained a right knee implant.
Root Cause Description:	Process control
Other Submission Description:	N/A
Action:	On 4/13, 14 and 15 Biomet made phone calls to the consignees to inform them of the recall. The firm sent Urgent Medical Device Recall Notices dated 4/20/2010. The customers were instructed to immediately locate the recalled products and return them to the manufacturer.
Product Quantity:	5
Distribution Pattern:	1 unit in US. 3 units in Biomet distributor inventory, 1 unit in Japan
Medical Speciality Description:	N/A
Regulation Number:	N/A
Event Date Posted:	2010-08-10
Device Class:	N/A
Open FDA:	{"k_number"=>["K111400", "K895962", "K871585", "K063732", "K123721", "K183596", "K991106", "K111785", "K001456", "K152704", "K772225", "K021559", "K884796", "K925242", "K122883", "K071220", "K023724", "K871776", "K201611", "K991461", "K954684", "K072281", "K222816", "K131116", "K140555", "K131019", "K091263", "K093806", "K220896", "K020383", "K923807", "K980632", "K223062", "K042883", "K904300", "K952271", "K012095", "K051146", "K944845", "K110547", "K111062", "K953274", "K200209", "K852059", "K032522", "K972501", "K172326", "K954818", "K914169", "K983004", "K181338", "K924940", "K100370", "K093567", "K150928", "K062768", "K142933", "K180750", "K994076", "K171045", "K082358", "K030367", "K221337", "K170106", "K110397", "K202740", "K031183", "K081400", "K211938", "K111492", "K110837", "K042343", "K040770", "K182370", "K142807", "K040964", "K030978", "K050539", "K936008", "K062037", "K060742", "K220705", "K884398", "K100981", "K925372", "K961482", "K140452", "K031201", "K970031", "K864671", "K102578", "K023416", "K894504", "K871769", "K161668", "K131398", "K021740", "K213389", "K192507", "K931960", "K924340", "K934589", "K922620", "K142388", "K153217", "K122991", "K070981", "K023788", "K151266", "K120790", "K102580", "K210252", "K813598", "K200407", "K834432", "K934354", "K123339", "K960279", "K002735", "K810326", "K030577", "K210829", "K983733", "K202429", "K003182", "K143242", "K923277", "K904205", "K183344", "K911198", "K843241", "K972967", "K894658", "K933610", "K123342", "K061882", "K042515", "K141585", "K010027", "K930595", "K190122", "K071738", "K082022", "K032151", "K143047", "K936037", "K915192", "K950010", "K892503", "K081023", "K971652", "K102367", "K113571", "K082826", "K961685", "K896542", "K093746", "K222700", "K963117", "K011904", "K180334", "K810328", "K122870", "K071991", "K170573", "K212411", "K132046", "K912147", "K901085", "K053579", "K131409", "K212839", "K143106", "K101499", "K160700", "K192084", "K060515", "K160342", "K160771", "K920426", "K210961", "K901406", "K972643", "K221479", "K802922", "K170613", "K131467", "K915584", "K003910", "K133560", "K091280", "K951987", "K062274", "K190911", "K031962", "K183017", "K926257", "K033260", "K082500", "K100542", "K915512", "K170753", "K152382", "K874635", "K971550", "K212034", "K131864", "K211609", "K222380", "K910990", "K012251", "K982585", "K170240", "K991753", "K133449", "K213673", "K954138", "K121835", "K120698", "K011219", "K050210", "K910500", "K933867", "K023528", "K932911", "K926334", "K073602", "K936274", "K052687", "K180743", "K131472", "K951956", "K190280", "K980276", "K140833", "K004013", "K892800", "K925900", "K953439", "K170806", "K912663", "K200826", "K915132", "K914072", "K060370", "K965173", "K182125", "K190562", "K110404", "K980999", "K962557", "K190577", "K946150", "K033890", "K150890", "K033883", "K882234", "K901936", "K932690", "K003296", "K991428", "K121443", "K082424", "K080199", "K113550", "K940813", "K790219", "K893040", "K141934", "K984054", "K190068", "K191192", "K972864", "K040630", "K902335", "K972752", "K943462", "K063211", "K972770", "K994128", "K882322", "K180906", "K090988", "K021451", "K994214", "K142069", "K193057", "K894937", "K181635", "K162222", "K132752", "K190402", "K871146", "K152430", "K140942", "K181569", "K202924", "K961021", "K920080", "K162273", "K931054", "K133630", "K963242", "K024037", "K080528", "K163167", "K131368", "K181146", "K063406", "K993159", "K112891", "K843242", "K020114", "K182251", "K982903", "K181947", "K935080", "K961483", "K963148", "K101032", "K954909", "K070095", "K933539", "K922869", "K970758", "K860654", "K193540", "K102795", "K112906", "K152726", "K170282", "K970498", "K931466", "K925901", "K210191", "K180493", "K171054", "K920698", "K200653", "K190355", "K963796", "K161705", "K000978", "K893762", "K112285", "K113482", "K053514", "K974556", "K895639", "K932210", "K142649", "K000091", "K102437", "K013991", "K020295", "K943025", "K904448", "K193223", "K030686", "K974843", "K212129", "K892366", "K960976", "K994370", "K864632", "K122033", "K153075", "K092201", "K183025", "K926228", "K103170", "K082019", "K150496", "K191755", "K193105", "K133342", "K023186", "K170149", "K080936", "K935773", "K001147", "K210695", "K202248", "K960535", "K123687", "K932246", "K905076", "K041825", "K914230", "K974328", "K133854", "K915798", "K033342", "K143443", "K040281", "K944321", "K031729", "K210551", "K102125", "K121879", "K140423", "K183583", "K112941", "K140027", "K122232", "K874547", "K103117", "K153595", "K180159", "K925072", "K896397", "K221939", "K853991", "K973121", "K933494", "K920524", "K921182", "K011976", "K870702", "K013906", "K033272", "K984291", "K875201", "K001307", "K140830", "K011288", "K200765", "K980925", "K123159", "K072336", "K121307", "K915186", "K022204", "K973595", "K930228", "K760200", "K133737", "K913492", "K943299", "K984623", "K930188", "K934166", "K934620", "K211004", "K881982", "K972626", "K922104", "K955884", "K113829", "K201851", "K830927", "K211877", "K040267", "K133919", "K201023", "K993111", "K792089", "K925837", "K962137", "K163332", "K941769", "K120068", "K840100", "K951027", "K121037", "K912894", "K161945", "K896081", "K143725", "K060569", "K130708", "K142787", "K002772", "K872134", "K222431", "K093552", "K021657", "K923443", "K060525", "K170648", "K120313", "K971189", "K910992", "K885036", "K833363", "K023211", "K990030", "K984158", "K183225", "K940713", "K913188", "K910940", "K170808", "K002678", "K870273", "K111283", "K012172", "K072858", "K914565", "K935262", "K153437", "K061340", "K161414", "K003026", "K002335", "K063633", "K021313", "K182301", "K000113", "K100391", "K121149", "K173057", "K042271", "K894403", "K111184", "K871772", "K111711", "K090411", "K173884", "K933290", "K071071", "K944285", "K041085", "K181732", "K182085", "K142404", "K896045", "K933958", "K024161", "K920034", "K183010", "K142550", "K873197", "K113325", "K843907", "K160159", "K922859", "K181530", "K930554", "K884338", "K033959", "K162035", "K940861", "K934381", "K150241", "K113122", "K221404", "K936159", "K861266", "K973406", "K173723", "K153721", "K113060", "K972774", "K002281", "K945087", "K012776", "K161366", "K971770", "K830121", "K935726", "K200227", "K964008", "K922734", "K201343", "K123692", "K011643", "K980545", "K864518", "K930190", "K905810", "K020830", "K893252", "K946088", "K051756", "K060722", "K874923", "K211671", "K962152", "K854883", "K160157", "K131481", "K873602", "K213793", "K212742", "K911197", "K082469", "K022672", "K904208", "K090705", "K173445", "K063423", "K131337", "K864627", "K103837", "K143635", "K183533", "K162775", "K192148", "K932677", "K210483", "K012866", "K901457", "K051977", "K140826", "K860594", "K853661", "K912245", "K924698", "K973164", "K140073", "K910235", "K932858", "K963255", "K855166", "K122765", "K933843", "K032215", "K160515", "K202022", "K071499", "K973672", "K982302", "K143226", "K211664", "K180930", "K964951", "K113378", "K180446", "K032606", "K890132", "K871349", "K173875", "K012778", "K921640", "K991882", "K993371", "K962196", "K041466", "K041106", "K980713", "K992167", "K021578", "K981996", "K120507", "K141471", "K910563", "K130084", "K131310", "K094017", "K952830", "K833921", "K182872", "K171389", "K953443", "K924482", "K083772", "K211602", "K022586", "K933304", "K142161", "K973524", "K101356", "K912266", "K032079", "K980637", "K072221", "K022010", "K863805", "K935789", "K122985", "K130143", "K983153", "K922841", "K172336", "K952943", "K101994", "K152170", "K991143", "K040166", "K032950", "K910989", "K150544", "K123457", "K103733", "K043101", "K080204", "K050723", "K960856", "K063686", "K920396", "K221059", "K200075", "K955421", "K901338", "K102380", "K041046", "K872266", "K053390", "K150829", "K200395", "K973412", "K121416", "K200912", "K934695", "K031901", "K171269", "K122975", "K153310", "K991052", "K971789", "K894334", "K051229", "K895145", "K131679", "K902246", "K220737", "K073286", "K851231", "K020214", "K170534", "K032829", "K060192", "K101281", "K094050", "K933785", "K936079", "K930831", "K935523", "K222278", "K110362", "K051640", "K961379", "K884410", "K162422", "K000590", "K120316", "K010434", "K122239", "K043440", "K122500", "K922285", "K140222", "K041591", "K173890", "K771598", "K905613", "K162026", "K870730", "K122183", "K963709", "K892394", "K932837", "K000666", "K940235", "K922048", "K202684", "K933289", "K172936", "K112780", "K094013", "K113369", "K972270", "K052879", "K911972", "K091014", "K781294", "K081127", "K883215", "K150783", "K160025", "K193284", "K000232", "K081458", "K931651", "K101981", "K030301", "K191625", "K991581", "K983835", "K981560", "K152494", "K883122", "K951185", "K904170", "K932425", "K210809", "K951655", "K152008", "K152169", "K191765", "K012348", "K901992", "K020703", "K833411", "K160484", "K120955", "K954208", "K932070", "K042993", "K093360", "K980781", "K872379", "K051976", "K161360", "K941306", "K100900", "K963028", "K012702", "K143192", "K042757", "K021908", "K915525", "K972863", "K930189", "K993692", "K173331", "K863668", "K010101", "K133256", "K932776", "K982869", "K001010", "K140902", "K150105", "K032295", "K011258", "K923451", "K896452", "K032479", "K933229", "K133162", "K073529", "K072531", "K093293", "K092803", "K130673", "K911572", "K213381", "K023546", "K132161", "K941755", "K002740", "K945589", "K123166", "K121640", "K203447", "K863667", "K182574", "K923573"], "registration_number"=>["1721676", "3010132111", "1219213", "9613369", "3012217062", "3013534757", "3023852420", "9610726", "1226188", "3010856250", "9613350", "1828464", "8043792", "1722511", "3010537287", "2528981", "3004638532", "3010673530", "3010400367", "1646498", "3007311878", "1423662", "3021239845", "2249615", "3010163695", "1219655", "3008182611", "3013450937", "1221763", "3006395932", "3006948478", "3010173425", "3010123256", "3008421730", "3012275107", "3011170410", "3011061242", "3010846112", "3010390570", "2648920", "3014302784", "3002806535", "9680215", "3016261144", "3009971621", "1818910", "1836001", "3015183635", "3007189546", "1833084", "3010039400", "1643817", "3004358587", "3002806470", "3002807112", "1319660", "3006946276", "9612277", "3003596442", "3009813841", "1835444", "3003477135", "3006694268", "3007923096", "3005641619", "3004748528", "2132732", "3026776", "3009844603", "9611390", "1526534", "3007516837", "3010178296", "3004976965", "3005061536", "3007675554", "3004196040", "1223434", "3009590742", "3010363503", "9681642", "9611579", "3010288357", "3013176080", "3007913880", "1000200989", "1645151", "3004776227", "3009106092", "3005913274", "3004995615", "3013014058", "3008556682", "3005652161", "1061927", "3009293341", "3010009693", "3010047454", "3005551626", "3008812251", "3010392243", "1064858", "3019261070", "3003587896", "3004513872", "3007366790", "2246552", "3009555440", "3006791286", "1720929", "3008572101", "1000550978", "3009998573", "1827096", "1057425", "1422549", "3015516266", "3008892118", "3014273644", "1832228", "3010468876", "3010576282", "3002807314", "3010886696", "3010266064", "3009185591", "3004153240", "1220246", "3014838274", "3008021110", "3013302242", "3009554293", "3006017180", "2133928", "3003387384", "8010764", "3016090213", "3008658204", "9617297", "3010770484", "3006128100", "3010531069", "3008868758", "1226544", "3007488163", "3010156421", "3000931034", "3020703621", "1450662", "3016470314", "3002807315", "1424263", "3006563559", "2183946", "2916714", "1054811", "3010057495", "3004889950", "3010386387", "2134470", "3013843055", "3016096064", "3014399756", "3010287737", "3009848551", "3009888740", "1644408", "3010165244", "3015167917", "1835251", "3010536692", "1649518", "3014315560", "3005677016", "3018051430", "2531477", "1724955", "3015259876", "1043653", "3011295718", "3010370880", "2244478", "3007420745", "3005140381", "3021008900", "3009887475", "3008262872", "3002907620", "3009732568", "3008544874", "3005360851", "3010375065", "2245304", "9617840", "3003765982", "9681258", "2249697", "3010898856", "3010162973", "2242737", "3008285983", "3002807295", "3008744062", "3005562917", "3005673311", "1048014", "3000264985", "3010120183", "1038671", "3002807310", "1000517406", "3006015326", "3003791208", "3006356043", "3006639916", "3007963827", "3015231789", "3015916578", "3005718816", "3006801265", "3010388970", "3004371426", "1529009", "1531174", "3010331645", "1526711", "3006406161", "3012491394", "3009582259", "2032521", "3009555447", "3005180920", "3009882462", "3013417938", "3004450489", "3010089671", "3005751028", "3012627386", "1825034", "3020967480", "3012439458", "3009973505", "3013186738", "3007353762", "3009973336", "1530390", "3004153896", "9681465", "9616680", "2134285", "1833920", "3005726022", "3002808022", "8010379", "3008110533", "3012392319", "3014763043", "3013055499", "3005596372", "3008985661", "3012725451", "3011461101", "9610612", "3000236920", "1835572", "3014644608", "3015398319", "1020279", "1828288", "3017298928", "1018470", "3009173317", "3005279746", "9616671", "3010462278", "3011187779", "3005852519", "3016851379", "3022142628", "3005581234", "9614841", "3020745236", "1833506", "3004086872", "1220477", "3007539489", "3002806603", "1822565", "1643264", "3006849754", "3016438694", "3007334927", "3010939823", "3003639920", "3021566676", "3003998208", "3009241418", "3017410889", "3011015572", "9614209", "3020155054", "3010220595", "3005144609", "2183744", "3012319330", "3010041693", "1834331", "3011274144", "3010097171", "1221053", "1218882", "3011724582", "3010041662"], "fei_number"=>["3003142829", "3002807172", "1721676", "3010132111", "1219213", "3012217062", "3013534757", "3023852420", "3010856250", "3002806773", "1828464", "3010537287", "2528981", "3004638532", "3010673530", "3010400367", "3007311878", "3021239845", "3010163695", "3000215273", "1219655", "3008182611", "3013450937", "1221763", "3006395932", "3006948478", "3002806725", "3010123256", "3008421730", "3012275107", "3011170410", "3011061242", "3010846112", "3010390570", "3014302784", "3002806535", "3016261144", "3009971621", "3000203000", "1818910", "3015183635", "3007189546", "1833084", "1000114185", "3010039400", "1643817", "3004358587", "3002806470", "3002807112", "1000116912", "3006946276", "3003596442", "3009813841", "3003477135", "3006694268", "3007923096", "3005641619", "3004748528", "1000395711", "3009844603", "3000717902", "1526534", "3007516837", "3004976965", "3005061536", "3007675554", "3004196040", "3009590742", "3010363503", "3010288357", "3013176080", "3008342029", "3007913880", "1000200989", "3004776227", "3009106092", "3002808269", "3005913274", "3004995615", "3013014058", "3008556682", "1000116116", "3005652161", "3003015552", "3009293341", "3010009693", "3002993297", "3010047454", "3005551626", "3002807893", "3003714383", "1000137563", "3010392243", "1000220733", "3002808293", "3003128516", "3019261070", "3003587896", "3007282753", "3000717687", "3004513872", "2246552", "3009555440", "3006791286", "1000136269", "1720929", "3008572101", "1000550978", "3009998573", "1827096", "3008397795", "3015516266", "3000215103", "3008892118", "3014273644", "1832228", "1000136478", "3010576282", "3002807314", "3010886696", "3010266064", "3009185591", "3004153240", "1220246", "3002462840", "3014838274", "3008021110", "1000143502", "3013302242", "3009554293", "3006017180", "3003387384", "3016090213", "3008658204", "3010770484", "3006128100", "3010531069", "3008868758", "3002465897", "3007488163", "3010156421", "3000931034", "3003574398", "3020703621", "1450662", "3003200961", "3001084824", "3016470314", "3002807315", "3006563559", "2916714", "3002459190", "3010057495", "3001452082", "3004889950", "3010386387", "3003386935", "3003070421", "3013843055", "3016096064", "3014399756", "3010287737", "3009848551", "3009888740", "3010165244", "3015167917", "3010536692", "3014315560", "3005677016", "3018051430", "1000086912", "1000221916", "3015259876", "1000159999", "1043653", "3011295718", "3010370880", "3002477077", "3007420745", "3005140381", "3021008900", "3009887475", "3008262872", "3002907620", "3009732568", "3008544874", "3005360851", "3010375065", "3001354499", "2245304", "3003765982", "3010898856", "3008285983", "3002807295", "3008744062", "3005562917", "1048014", "3000264985", "3010120183", "3003110073", "1038671", "3002807310", "1000118610", "1000517406", "3006015326", "3003791208", "3006356043", "3006639916", "3007963827", "3015231789", "3015916578", "1000306340", "3005718816", "3006801265", "3001236277", "1000199976", "3010388970", "3010331645", "1526711", "3006406161", "1000149660", "3012491394", "3005601732", "3009582259", "3002854251", "1832656", "3009555447", "3005180920", "3009882462", "3013417938", "3004450489", "3010089671", "3005751028", "3002806315", "3012627386", "1825034", "3020967480", "3012439458", "3009973505", "3013186738", "3007353762", "3009973336", "3005233524", "3000205591", "3001642380", "3005985723", "3004153896", "3002807036", "1000135253", "1000132037", "3002808022", "3008110533", "3001548076", "3012392319", "3014763043", "3013055499", "3005596372", "3008985661", "3012725451", "1000306694", "3011461101", "3002904345", "3002807328", "3002807113", "3014644608", "3015398319", "1020279", "1828288", "3017298928", "1018470", "3009173317", "3005279746", "3010462278", "3011187779", "3005852519", "1000115656", "3016851379", "3022142628", "3005581234", "3020745236", "3004086872", "1220477", "3007539489", "3002806603", "1643264", "3002287318", "3006849754", "3016438694", "3007334927", "3010939823", "3003639920", "3021566676", "3002807041", "3003998208", "3009241418", "3001049282", "3011015572", "3020155054", "3010220595", "3005144609", "2183744", "3012319330", "3010041693", "3011274144", "3002808402", "3010097171", "1221053", "1218882", "3011724582", "1000138247", "3010041662"], "device_name"=>"Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer", "medical_specialty_description"=>"Orthopedic", "regulation_number"=>"888.3560", "device_class"=>"2"}