Class 2 Device Recall LFIT Anatomic CoCr Femoral Heads

• Date Initiated by Firm: May 22, 2018
• Create Date: October 11, 2018
• Recall Status: Terminated on May 08, 2020
• Recall Number: Z-2292-2018
• Recall Event ID: 80059
• 510(K)Number: K022077
• Product Classification: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
• Product: LFIT Anatomic CoCr Femoral Heads, 6260-9-036
• Code Information: Lots 10176601 10176602 10446901 10852601 10937801 11121001 11121002 11969801 11969802 12204501 12204502 12204503 12668301 12668302 12668303 13365101 13365102 13365103 14101701 14101702 14390201 14390202 15186701 15186702 15186703 15292201 15341301 15629301 15759301 16462501 16575502 16637001 16666801 16684301 17158901 17158902 17230301 17230302 18133801 18133802 18133803 18216101 18216102 18216103 18783601 18783602 19313601 19313602 19313603 19313604 19506101 19506102 19549501 19549502 19614801 19614802 19614803 19691301 19691302 19715701 19738101 19738102 19738103 19780201 19780202 19843901 19843902 20167601 20479101 20479102 35007304 35246401 35826901 35826902 35826903 35826904 35826905 36140401 36140402 36140403 36140404 36140405 36467201 36467202 36467203 36467204 36993801 37014601 37014602 37014603 37014604 37014605 37034301 37034302 37252501 37252502 37252503 37367101 37367102 37367103 37367104 37708901 37708902 37708903 37708904 38044501 38044502 38044503 38044504 38044505 38044506 38287401 38287402 38287403 38287404 87530201 87530202 87530203 87530204 87530205 87530501 87530502 87530503 87530504 87535501 87544601 90469601 90469602 92059101 92059102 92059103 92059104 92677301 92677302 93490501 93490502 93639401 93639501 93982601 93982602 36LMKA 374MKA 37KMMD 37PMTD 37RMTD 37TMTD 38449701C 38449702C 38449703X 38449704C 38449705C 394MKA 39JMMD 3AHMNE 3AVMNE 3AWMNE 3AWMNEX1 3JYMNA 3K3MNA 3KDMNA 3KDMNAX1 3KKMNA 3KKMNAX1 3MDMHD 3MJMMD 3NWMNE 3P2MHA 3P4MHA 3P5MHA 3P6MHA 3P7MHA 3PLMKD 3PPMKD 3T4MKD 3WJMMD 400MNE 401MNE 426MMD 42EMMD 438MHD 43LMTD 43MMTD 43NMTD 451MHD 47LMHD 48JMHD 48PMHD 49AMPD 4D6MHE 4D7MHE 4D8MHE 4V5MPE 4V5MPEX1 4VDMPD 4VDMPDX1 4WLMPE 4XJMKD 4XLMKD 4YPMKD 539MPE 53MMPD 53NMPD 57NMPE 59KMMD 59LMMD 59VMJE 5A1MKD 5A5MJE 5A7MJE 5K6MPE DTVMJD DYPMKE E16MDD E63MPD E6HMND E6LMPD E6LMPDX1 E6WMPD E6WMPDX1 E6YMND E7HMDD E7KMDD E7KMDDX1 E7LMDD E92MTA E93MTA E94MTA E95MTA E95MTAX1 EHRMNE EJ0MAE EJ4MAE EVDMAE EVLMNE EWJMMD H2XMAE H30MAE H31MAE HARMTD HARMTDX1 HHPMMD HHTMMD HHXMMD HJLMTD HJXMDD HJXMDDX1 HJYMDD HK3MLD HNAMDD HNAMDDX1 HNTMLE HV2MLE HV2MTD J4JMLE J5RMND J5RMNDX1 J5XMND J68MKE J68MKEX1 J69MKE J6HMND J71MLE J83MLE J8LMLE J9LMPA J9MMPA J9NMPA JD1MDE JE4MLE JEJMKE JJ8MLE JK4MDE JM4MDE JM6MTD JM7MTD JM7MTDX1 JM8MTD JMNMTD JMPMTD JMRMTD MET5JR MET5JRX1 MET5JV MET63E MET63H MET63J MET6PM MET6YJ MET724 MET727 MET7JY MET7K7 MET7KL MET7KLX1 MET7LH MET7LN MET80W MET87X MET8MR MET9W3 MET9W3X1 MET9W5 MET9XT MET9XV META3H META3HX1 META3HX2 META6V META6X METAA9 METAAE METAE5 METAMN METAR9 METARK METATA METAV5 METAV6 METAV7 METAV7X1 METAVE METAWA METAY7 METMR3 METMR3X1 METMVN METMXV METMY1 METMY5 MHA3WV MHA4DT MHA4JN MHAHVL MHAJ4L MHAJLA MHAJMX MHAJP6 MHAJPR MHAJRA MHAJWR MHAK0X MHAK41 MHAKHD MHAKM7 MHAKM7X1 MHAKW3 MHAKW7 MHAL07 MHAL0N MHAL42 MHJH9X MHJH9XX1 MHJHAN MHJHKJ MHJHTM MHJHVW MHJHVX MHJJ63 MHJJ7X MHJJ85 MHJJ8V MHJJ8Y MHJJR3 MHJJVL MHJLAJ MHJLEK MHJLR6 MHJM24 MHJM38 MHJM4K MHJM65 MHJMPR MHJR7P MHJRDY MHJRE0 MHJRH6 MHJRKR MHJRW2 MHJT0M MHJT1R MHJT24 MHK838 MHK86X MHK8HE MHK8NP MHK8VH MHK938 MHK93J MHK94Y MHK995 MHK9JN MHK9L9 MHK9LA MHK9LD MHKA09 MHKA1J MHKA1T MHKA32 MHKA4A MHKA4E MHKA83 MHKA87 MHKA9E MHKA9K MHKAAT MHKAAV MHKAP4 MHKAP7 MHKD36 MHKD75 MHKD8M MHKD8V MHKD8W MHKDA2 MHKDJL MHKDM4 MHKDM5 MHKDWE MHKDWH MHKE3D MHPM5H MHPM5M MHPM5N MHPM69 MHPMAE MHPMJK MHPMNL MHPMW5 MHPN94 MHPRNL MHPVAX MHR9LV MHR9P7 MHR9PA MHR9PL MHR9PT MHR9R4 MHR9RX MHR9WR MHRA14 MHRA9J MHRAN1 MHRARK MHRAT3 MHRAT4 MHRAVA MHRD06 MHRD2E MHRD2N MHRD61 MHRDAW MHRDEJ MHRDW6 MHRDXR MHRDXT MHRDY7 MHRDY8 MHRE00 MHRE2E MHRE32 MHRE4P MHRE5H MHRE8J MHREJK MHRELA MHRETV MHRH3V MHRH5M MHRH5T MHRT87 MHRTA2 MHRTAK MHRTDN MHRTDX MHRTDY MHRTE0 MHRTLA MHRTRN MHRV49 MHT272 MHT2HM MHT2LW MHT2LWX1 MHT2Y8 MHT31P MHT33E MHT3EH MHT3L2 MHT3L5 MHT3M5 MJHT9X MJJ2HD MJJ2HH MJJ2HJ MJJ305 MJJ307 MJJ308 MJJ39A MJJ441 MJJ46A MJJKA1 MJJKAA MJJKAP MJJKL1 MJJKX6 MJJKX7 MJJKX9 MJJLLN MJJLNM MJJLT6 MJK03M MJK082 MJK0J9 MJK0WP MJK0WT MJK0WV MJK112 MJK113 MJK114 MJK171 MJK1D6 MJK1MH MJK1V9 MJK1VA MJK1VD MJK26W MJK26X MJK26Y MJK2DW MJK2DX MJK2DY MJK2TD MJK2TE MJK2TH MJK78P MJK7N1 MJK7TE MJK8KE MJK8M7 MJK8MA MJK91M MJKK0E MJKKAM MJKKJV MJKKKL MJKKKN MJKKKP MJKKWX MJKKWY MJKKX0 MJKL53 MJKL84 MJKLH2 MJKLJ6 MJKLLD MJKLLE MJKLLH MJKYAY MJKYMP MJKYV7 MJPXRK MJPXT6 MJPXV2 MJPY4J MJPY59 MJPYR3 MJR1W0 MJR1X9 MJR218 MJR27W MJR339 MJR47L MJR4PK MJR51K MJR53K MJR5XH MJR6N2 MJR6NE MJR7T6 MJR7YN MJRAKP MJRED9 MJREEX MJRH90 MJRHK1 MJRHV3 MJRHX0 MJRKAK MJRKW9 MJRLXY MJRM6L MJRMHJ MJRMPH MJRN3D MJRNWT MJRPYA MJRRNV MJRT3D MJRTDM MJRTM2 MJRV0V MJRV5X MJRVEY MJRW56 MJRW7R MJRWMR MJRXY8 MJT02V MJT03L MJT09K MJT156 MJT18J MJT1Y7 MJT22Y MJT29P MJT36N MJT3TW MJT4JN MJT4TK MJT68D MJT6NX MJT6PE MJT6T0 MJT8H5 MJT9N2 MJT9YN MJTAVT MJTAX5 MJTD4A MJTD6X PMEMHD PMTMPD PN4MHD PNEMHD PNVMKA PNWMKAX1 PTKMEA PTLMEA PTMMEA PTNMEA PV4MJE PVNMME PVPMME PVRMME PXYMPD PYAMKE PYXMPD R3YMKE R5KMKE R6TMKA R6VMKA R6VMKAX1 RAHMKD RJ5MKA RJKMKA RL4MKA RL4MKAX1 RLPMKA RLPMKAX1 RLRMKA RM4MKA RM5MKA RM8MHE RM9MHE RM9MHEX1 RMAMHE RMAMHEX1 RT3MAD RT5MEA RT6MEA RT7MEA RT8MEA RV7MNA RV8MAD RV8MADX1 RV8MNA RV9MAD RV9MADX1 RV9MNA RVAMAD RVAMNA RVDMAD RWPMEA RWTMEA RYYMAD T00MAD T00MADX1 T05MAD T05MADX1 T06MAD T07MAD T08MAD T09MAD T24MLD T25MLD T25MLDX1 T29MLD T2DMLD T59MLD T5YMLD 20479103 20479104 20479105 20479106 20479107 20479108 20513301 20513302 20620701 20620702 20620703 20620704 20620705 20620706 20620707 20620708 20637401 20637402 20637403 20637404 20683501 20683502 20683503 20684301 20684302 20684303 20704801 20724301 20731701 20746401 20783101 20783102 20783103 20783104 20783105 20783106 20783107 20783108 20904301 20904302 20904303 20904304 20936201 20936202 20936203 20936204 21035201 21035202 21035203 21035204 21035205 21109701 21109702 21109703 21109704 21135001 21135002 21135003 21135004 21151601 21208301 21208302 21208303 21208304 21208305 21263901 21263902 21263903 21263904 21263905 95178501 95501401 95501402 96144101 96144102 96144103 96144104 96419901 96893801 96893802 97136501 97136502 98094301 98883401 99063601 99349901 99349902 00HMLE 00JMLE 00KMLE 00LMLE 00PMPE 00YMJA 02JMEE 02KMEE 02KMPE 02LMEE 038MPD 07HMPE 08WMED 08WMEDX1 095MJA 097MJA 09MMJA 0AWMRD 0KEMPE 0KRMPD 0L1MJA 0MPMNA 0MPMNAX1 0MRMNA 0N5MJA 0N6MJA 0NLMDD 0NMMDD 0NNMDD 0NPMDD 0PYMRD 0RTMED 0RTMEDX1 0RVMED 0RWMED 0RWMEDX1 0TAMPE 0V1MPD 0V2MRD 0V3MRD 0VMMDE 0VVMRD 0W2MRD 0WNMPA 0WNMPAX1 0WRMPA 0WRMPAX1 0WTMPA 0WTMPAX1 0XTMPE 0Y5MLE 0Y6MLE 0Y7MLE 5LDMKD 5PNMPE 5Y6MPE 5Y9MPE 5YAMPE 61XMHE 620MHE 621MHE 63DMPE 63KMPE 63KMPEX1 68YMPA 68YMPAX1 690MPA 690MPAX1 690MPAX1X1 690MPAX2 692MPA 692MPAX1 6KJMND 6KKMND 6KLMND 6MLMEE 6MMMEE 6MNMEE 6NEMED 6P0MED 6P5MJE 6P8MED 6P8MEDX1 6P9MED 6T3MPA 6T3MPAX1 6V5MDE 6VWMHE 6VXMHE 6VYMHE 6X0MDE 6X1MDE 700MPA 700MPAX1 70KMPD 72JMPA 72JMPAX1 72KMPA 734MJE 738MME 74NMDE 74PMDE 74PMDEX1 74RMDE 75RMDE 776MJE 795MNE 799MME 7E9MJE 7EAMJE 7EDMJE 7HAMNE 7JYMJE 7K4MJE 7K7MJE 7KXMEE 7KYMEE 7L0MEE 7MTMJD 7MVMJD 7MWMJD 7MXMJD 7MYMJD JNMMLE JNNMLE JNPMLE JNRMLE JRDMHE JREMHE JRHMHE JV1MND JWKMND JWYMAD JWYMADX1 JYMMPA JYNMPA K0XMND K0YMND K0YMNDX1 K1AMMD K36MND K37MND K3MMMD K3NMMD K42MEE K5RMAD K5RMADX1 K5TMAD K5VMRD K5VMRDX1 K6JMAE K6JMAEX1 K6MMAE K6RMAE K7RMAD K7TMAD K7TMADX1 K7VMAD K7XMAD K7XMADX1 K7YMAD KEHMRD KEJMRD KEKMRD KELMRD KEMMRD KKLMKD KKMMKD KKPMKD KNJMDD KNKMDD KNKMDDX1 KNKMKD KNLMDD KNLMKD KNMMDD KNMMDDX1 KNMMDDX1X1 KPDMKD L10MEE L11MEE L12MEE L1KMTD L1LMTD L1MMKA L1MMTD L3EMJE L4XMJE L54MEE L55MJE L6MMJE L6NMJE L6PMJE MHAL7T MHALEW MHALR7 MHALY9 MHAVXL MHAVY3 MHAW1A MHAW6H MHAW6HX1 MHAW9E MHAW9EX1 MHAWMH MHAWRW MHAWT7 MHD012 MHD012X1 MHD013 MHD014 MHD11L MHD125 MHD12A MHD154 MHD1A9 MHD1LM MHD991 MHD9HY MHD9TN MHD9VW MHD9XL MHD9Y3 MHD9YD MHD9YDX1 MHD9YDX2 MHD9YH MHDA2V MHDA2VX1 MHDA6J MHDAL5 MHDAL5X1 MHDATR MHDD0R MHDD1M MHDD3J MHDD47 MHDXXH MHDXXHX1 MHDXXHX1X1 MHDY0D MHDY1A MHDY2A MHDY3P MHDY4D MHDY4DX1 MHE0N3 MHE0TV MHE10L MHE10W MHE11T MHE126 MHE146 MHE18N MHE79W MHE7M4 MHE7MT MHE7NR MHE7R9 MHE7RE MHE7RT MHE7TN MHE7V3 MHKE6P MHKE7M MHKE8A MHKE8K MHKE91 MHKEDM MHKEY8 MHKH29 MHKH29X1 MHKH7M MHKH86 MHKH94 MHKHER MHKHTN MHKHTR MHL73P MHL73R MHL73T MHL8EH MHL8EJ MHL8H0 MHL8LP MHL8WX MHL97E MHL97K MHL9KR MHL9V8 MHL9VW MHL9W1 MHL9X7 MHL9X8 MHLA79 MHLA7A MHLA7E MHLA7H MHLAWR MHLD05 MHLD18 MHLD1E MHLD3P MHLD3R MHLD3T MHLD3W MHLD3X MHLE43 MHLXH7 MHLXLP MHLY68 MHLYAP MHLYD2 MHLYD4 MHM002 MHM006 MHM016 MHM057 MHM06N MHM07M MHM07MX1 MHM0E8 MHM0JL MHM0V0 MHM0VW MHM0YE MHM102 MHM103 MHM103X1 MHM116 MHM137 MHM138 MHM139 MHT3R0 MHT3R1 MHT3R3 MHT69A MHT6KD MHT6PD MHT6VW MHT750 MHT754 MHT78P MHT78R MHT9H5 MHT9H7 MHT9H9 MHT9HA MHT9HD MHT9HE MHTA8X MHTA8Y MHTAA6 MHTANR MHTAPD MHTAWY MHTD18 MHTD7P MHTD9K MHTD9Y MHTDLE MHTDLK MHTDMJ MHTDP3 MJA2PR MJA2PV MJA2TL MJA2TM MJA2YL MJA2YP MJA336 MJA337 MJA357 MJA359 MJA3DV MJA3JR MJA3K4 MJA3LD MJA3LN MJA3N0 MJA3N1 MJA3P7 MJA3RW MJA41N MJA43D MJA456 MJA49X MJA4ER MJA4R2 MJA4WL MJA4Y2 MJA4YP MJA507 MJA51M MJA55M MJA560 MJA6D4 MJA6D5 MJA6D6 MJA6RA MJA70E MJA76P MJAMYA MJL005 MJL10J MJL10V MJL3XR MJL48D MJL4YT MJL698 MJL7J0 MJL7KM MJL7LD MJL7XR MJL7Y9 MJL956 MJL9AJ MJL9L2 MJLD92 MJLDT0 MJLEE2 MJLEE3 MJLEE4 MJLEP5 MJLHDX MJLHE9 MJLHM1 MJLHM2 MJLHW4 MJLJY1 MJLKDX MJLKX3 MJLLV1 MJLMKR MJLN81 MJLNA4 MJLNW5 MJLR8X MJLTMK MJLV7X MJLW0J MJLW3J MJLX0E MJLXPH MJLY7D MJLYEK MJM1T7 MJM2M1 MJM2P6 MJM34P MJM388 MJM3A3 MJM3EH MJM3ME MJM46Y MJM47V MJM54X MJM56P MJM5WL MJM6Y2 MJM76J MJM774 MJM8HR MJM8PJ MJM8WK MJM967 MJMAHV MJMD70 MJMDP0 MJMDP1 MJME06 MJME0N MJME34 MJTD7L MJTDNX MJTEKD MJTEKN MJTEYL MJTJ1X MJTJ4M MJTJ4Y MJTJAH MJTK4X MJTKL7 MJTPMV MJTT78 MJTTK5 MJTVKY MJTW3D MJTXDW MJTXH3 MJTXKP MJTXY9 MJTY5D MJTY88 MJTY94 MJTYKT MJTYMV MJTYX9 MK9MHD MKA03H MKA057 MKA0L6 MKA1M7 MKA23L MKA2RT MKA5JN MKA5KD MKA65Y MKA6YE MKA6YT MKA817 MKA8H9 MKA95A MKA95N MKAEYL MKAH41 MKAJEW MKAJWV MKAK69 MKAL75 MKALL3 MKAM8K MKAM9Y MKAMHD MKAN1V MKAN3H MKANLV MKANYM MKAR2Y MKARNA MKARNK MKARVW MKAV50 MKAWHV MKAX5T MKAY32 MKAYET MKAYT3 MKD0LV MKD0RK MKD10X MKD12L T67MLD T6AMLD TD6MLE TEPMLE TJ2MLE TL0MEA TLMMEA TLNMEA TPYMNE TRMMJE TRPMJE TTYMMA TV0MMA TVHMEE TVJMEE TVKMEE TX0MED V0EMME V27MED V5TMJE V5VMJE V5WMJE V79MMD V8RMED V9LMMD VAKMLE VE3MEE VE5MEE VE6MEE VHNMMD VKWMNE VL1MNE VL3MEE VLAMMD VLHMED VM7MED VMLMNE VTKMME VTPMNE VTWMNE VTXMNE VV0MME VV0MMEX1 VV4MMA VV4MMAX1 VWKMMA VWKMMAX1 VWVMMA VYKMMD VYMMMD W02MMD W03MMD W04MMD W12MNE W13MNE W4EMJE W7EMJE W7LMLE W83MJE W89MLE W8KMNE W8PMNE WDKMHE WKJMJA WKNMJA WL1MHE WL2MHE WL4MHE WL6MHE WL7MHE 21451901 21451902 21451903 21451906 21473701 21473702 21473703 21473704 21473705 21473706 21491501 21491502 21491503 21491504 21491505 21696001 21743801 21743802 21743803 21743804 21762304 22562601 22610301 22610302 22621701 22621702 22829501 22829502 22829503 23550701 23550702 24123001 24123002 24142501 24142502 24295101 24295102 24844701 24844702 24876401 24941801 25259901 25259902 25259903 25467301 25467302 25467303 25467304 26115701 26115702 26115703 26205801 26205802 26381001 26381002 27258001 27294101 27294102 27294103 27377201 27377202 27377203 28125401 28125402 28125403 28125404 28125405 28789801 28789802 28789803 0YMMNE 103MTD 105MTD 106MTD 108MTD 109MTD 10AMTD 10WMPE 10XMPE 10YMPE 117MLE 118MLE 119MLE 12204503A 122MHD 12KMNE 12LMNE 12TMDE 12VMDE 12WMDE 12WMPE 13VMNE 14DMNE 14VMPE 15VMKD 17LMHD 19313601X1 19313602X1 19313602X1X1 19313602X2 19313603X1 19313604X1 19506102X1 19549502X1 19549502X2 19614801X1 19614802X1 19614802X2 19614803X1 19738101X1 19738102X1 19738102X1X1 1E2MHD 1EP01X 1EP02J 1EP02W 1EP02WX1 1EP033 1EP088 1EP08A 1EP08D 1EP08E 1EP08J 1HEMEE 1JK0DY 1JK0L7 1JK0NA 1LVMKD 1P1MHD 1PRMEE 1T7MLE 1X4MMD 1XHMMD 1XHMMDX1 20479101X1 20479101X2 20479102A 20479102X1 20479103X1 20479104X1 7N0MJD 7N1MJD 7N2MJD 7N3MPD 7P7MME 7R1MME 7Y9MME 80JMCA 80KMCA 80LMCA 80MMCA 81JMME 81RMND 81TMND 81TMNDX1 81VMND 822MME 83DMME 83EMME 841MME 848MME 85PMME 87530202A 8D7MLD 8D7MLDX1 8HRMJE 8KPMDE 8KRMJE 8L2MEE 8LYMJE 8M6MJE 8MAMLD 8NRMJE 8P0MJE 90MMJE 91XMLD 92059103A 92LMLD 93490502A 96893801A 9H1MDA 9H2MDA 9H3MDA 9H4MDA 9H5MDA 9H6MDA 9HRMRD 9JDMRD 9JNMRD 9JTMNE 9KRMLD 9KXMRD 9M4MLD 9M9MND 9M9MNE 9MDMND 9MEMNE 9MHMND 9MMMDE 9MNMDE 9MPMDE 9MPMDEX1 9R9MNE 9T1MRD 9XWMRD A0AMED A0JMPD A0NMPD A0VMPD A10MRD L8NMEE L92MEE LD6MKE LD8MKE LD8MKEX1 LDAMKE LDLMEE LHRMPD LKYMPD LL1MEE LMMMHA LMNMHA LMPMHA LP9MHA LPAMHA LPDMHA LPEMHA LPHMHA LPYMHA LR0MHA LR1MHA LRKMAD LV0MPD LV0MPDX1 LXMMKA LXNMKA LXRMKA M22MHE M22MHEX1 M23MHE M24MHE M2LMPD M65MPD M79MAE M9HMKA M9HMPD M9JMKA M9JMPD M9JMPDX1 M9KMPD M9LMPD M9NMKA M9PMKA M9RMKA MA2MAE MA2MJA MA3MAE MA4MAE MEEMHD MEJMHD MEKMHD MELMHD MEPJHY MEPJT3 MEPL22 MEPL58 MEPLA7 MEPLA7X1 MEPLAH MEPLKD MEPLKDX1 MEPLKDX2 MEPLLT MEPLLY MEPLN1 MEPMV6 MEPMW3 MEPMW4 MEPMW4X1 MEPMW5 MHE91E MHE92D MHE93D MHE956 MHE956X1 MHEEA6 MHEEA6X1 MHEENM MHEENMX1 MHEEWP MHEH46 MHEHE2 MHEHE2X1 MHEHWE MHEHWEX1 MHEHWV MHEHWVX1 MHEHXY MHEHXYX1 MHEJ00 MHEJ4N MHEJ4NX1 MHEJ7H MHEJLW MHEJLWX1 MHEJWN MHEJWNX1 MHEK0X MHEK0XX1 MHEK27 MHEK2N MHEK32 MHEK32X1 MHEK85 MHEK85X1 MHETH0 MHETH0X1 MHETHD MHETLR MHETLT MHETNN MHETNT MHETNTX1 MHETW1 MHETWP MHEVE1 MHEVKT MHEVVH MHEVVHX1 MHEVWN MHEVWNX1 MHEVX7 MHEY67 MHEY67X1 MHH2XK MHH2Y2 MHH2Y2X1 MHH2Y7 MHH2YH MHH32T MHH34N MHH34P MHH34PX1 MHH3KV MHH3XE MHH3XX MHH3XXX1 MHH40V MHH41D MHH41J MHM13A MHM13AX1 MHM13D MHMA91 MHMA92 MHMA92X1 MHMA93 MHMA94 MHMA95 MHMA95X1 MHMA95X2 MHMA96 MHMA97 MHMA98 MHMA99 MHMA9A MHMA9D MHMA9E MHMA9H MHMA9J MHMA9K MHMA9L MHMA9M MHMA9N MHMA9NX1 MHMA9P MHMA9R MHME7T MHMTNY MHMTW7 MHMTW7X1 MHMV4N MHMV4NX1 MHMV5A MHMV5AX1 MHMVD0 MHMVD3 MHMVJ1 MHMVJ1X1 MHMVJN MHMVJNX1 MHMVKK MHMVLH MHMVM9 MHMVM9X1 MHMVR4 MHMVY7 MHMVY7X1 MHMW15 MHMW4V MHMW7T MHMWD7 MHMWD8 MHMWM2 MHMWM3 MHMWME MHMWMP MHN00K MHN02N MHN08M MHN0EX MHN0TJ MHN0VL MHN0VM MHN0VN MHN0XN MHN10M MHN1L1 MHN1TD MHN1VR MJAMYD MJAMYE MJAN7W MJAN7X MJAN7Y MJANAY MJANDJ MJANDK MJANDL MJANDM MJANDN MJANDP MJAP61 MJAP65 MJAP68 MJAP6E MJAP6K MJAPT8 MJAPT9 MJAPTA MJE0AP MJE1HH MJE1LW MJE1P3 MJE295 MJE2H7 MJE2W2 MJE34D MJE3M3 MJE3R6 MJE3VE MJE3XP MJE45D MJE4XX MJE4Y4 MJE527 MJE586 MJE7AK MJE7AM MJE7H9 MJE7HL MJE7HM MJE87X MJE896 MJE89J MJE8LN MJE8LR MJEHW7 MJEJ91 MJEJEY MJEJHW MJEKE0 MJEKKA MJEKND MJEKNE MJEP1K MJEP1M MJEP1Y MJEP9A MJEPK0 MJEPKN MJEPPN MJERA1 MJERA2 MJERA4 MJERJH MJERJJ MJERJK MJERRE MJERXA MJMEMR MJMEXL MJMH3X MJMJ2M MJMJA7 MJMJD6 MJMJHT MJMJTX MJMN0L MJMP41 MJMPM1 MJMR7T MJMRKA MJMT48 MJMW49 MJMW4T MJMW8W MJMWA3 MJMX7P MJMXR4 MJMY6E MJMYE7 MJMYXP MJN0R2 MJN1LJ MJN1X3 MJN294 MJN2N8 MJN2T6 MJN386 MJN3M6 MJN3XY MJN413 MJN44H MJN479 MJN5A9 MJN5J3 MJN5NR MJN5R2 MJN6RK MJN89A MJN8DA MJN9AH MJNA24 MJND2P MJND54 MJNDED MJNEJ3 MJNEVV MJNHW1 MJNHWN MJNJA1 MJNJDR MJNJJE MJNK3D MJNKDR MJNKHW MJNKTR MJNMWN MJNN2Y MJNN4T MJNNJ9 MJNNT8 MJNNWJ MJNPNE MJNPNR MJNR3E MJNRP8 MJNRPY MJNRTM MKD1NJ MKD1VH MKD340 MKD39E MKD3MM MKD45M MKD47H MKD4XH MKD5XE MKD6R9 MKD84K MKD8N1 MKD8XP MKD94R MKD9XX MKDDH0 MKDDJD MKDE6X MKDHXJ MKDJ6L MKDJMD MKDK51 MKDLK8 MKDM7W MKDM96 MKDMW8 MKDN32 MKDNY3 MKDPJY MKDR5K MKDRJY MKDT2V MKDTX3 MKDV84 MKDWVP MKDXPA MKDYEJ MKDYLW MKE506 MKED9P MKEJY1 MKEKYW MKER0L MKEVMK MLEMEE MLHMEE MLJMEE MM3MHA MM4MHA MM5MHA MM6MHA MM7MHA MM8MHA MMPMHA MR8MKD MTRMJA MTVMJA MTWMJA MVPMDE MW0MEA MW1MEA MW6MLE MW7MLE MW8MLE MWPMNA MY5MKD MY7MKD MYTMHE MYVMHE N00MHE WXXMMA WXXMMAX1 X0DMPD XE4MAE XEDMDE XEEMDE XEHMDE XNVMAE XNYMHA XP2MHA XP7MAE YNRMJE YNTMJE YNVMJE 28857701 28857702 29265201 29265202 29265203 29265204 29966501 29966502 29966503 29966504 29969301 29969302 29969303 30287101 30287102 30309301 30597001 30597002 30597003 30700401 30700402 30877401 30877402 30877403 31309401 31309402 31309403 31829101 31829102 31829103 31829104 32217101 32242001 32280701 32658101 32658102 32658103 32658104 32773701 32773702 32798501 32798502 33187901 33187902 33234301 33235801 33602501 33602502 33602503 33602504 33994701 33994702 33994703 33994704 33994705 34354801 34354802 34354803 34354804 34354805 34793901 34793902 34793903 34793904 34793905 34838601 34838602 35007301 35007302 35007303 20479104X1X1 20479105X1 20479105X1X1 20479105X2 20479106X1 20479107X1 20479108X1 20479108X2 20513301X1 20513302X1 20513302X2 20620707X1 20620708X1 20783105X1 20936201D 20JMEE 20TMKD 21109701X1 21208301X1 21208305X1 21263901X1 21263904X1 21263905X1 21473702X1 221MEE 221MEEX1 226MMD 238MEE 23DMEE 23DMHD 23EMHD 23HMHD 23TMLE 24844701D 24DMLE 24EMLE 24MMLE 25KMHD 25KMHDX1 26115701D 26205801D 26205802A 269MKD 29AMTD 29DMTD 29EMTD 2HEMEE 2J3MKD 2J8MKA 2LVMMD 2MYMHE 2N0MHE 2N1MHE 2WDMKD 2WLMMD 30LMKA 315MKD 325MKD 34AMEA 34DMEA 34DMKD 34EMEA 34HMEA 34JMEA 34KMEA 34LMEA 34VMKA 354MHA 35LMKA 36KMKA A17MEE A18MEE A19MEE A1AMEE A1DMEE A1EMEE A2JMRD A2PMRD A2PMRDX1 A31MTA A33MTA A34MTA A34MTAX1 A68MME A6TMME A6VMME A6WMME A6XMME A6YMME A85MLD AH4MLD AH4MLDX1 AL3MED ALTMLD ANTMED AT9MME AWHMHE AWMMHE AWPMHE AX5MED AXDMED AXMMED D0XMAE D0YMAE D10MAE D1JMJD D22MHD D2NMHD D38MHD D59MME D5NMME D5YMME D6DMKE D9DMTA D9EMTA D9EMTAX1 D9KMTA D9MMTA DA4MJD DA8MLA DAHMLA DAHMLAX1 DAVMJD DAWMJD DAWMJDX1 DAXMJD DELMKE DHDMHE DHEMHE DHHMHE DMNMKE DNWMKA DNYMKA DP0MKA DT2MED DT3MED DT4MED DT6MED DT7MED DTRMJD MEPNE8 MEPNE9 MEPNE9X1 MEPNEA MEPNEAX1 MEPVT4 MEPWP7 MEPWRY MEPWT0 MEPWTL MEPWVD MEPWVE MEPWVEX1 MEPX2N MEPX2NX1 MEPY7P MEPY92 MEPYEV MEPYM7 MEPYVD MEPYVDX1 MEPYXM MER0NW MER0NX MER0NXX1 MER12A MER161 MER3DP MER3M3 MER3M3X1 MER3WK MER41X MER474 MER4D4 MER4D8 MER4D8X1 MER4K2 MER4K2X1 MER4KD MER4KL MERALP MERALPX1 MERALR MERDA4 MERL3J MERL3K MERL3KX1 MERL3L MERL3LX1 MERL8T MET0HA MET0HN MET0HP MET0T6 MET0T7 MET11H MET11P MET11R MET11RX1 MET11T MET11V MET11W MET22E MET22L MET22M MET47N MET47NX1 MET47P MET47R MET5JP MHH41JX1 MHH47P MHH4LR MHH4PR MHH53D MHH53DX1 MHH547 MHH548 MHH55R MHH55RX1 MHH55T MHHDJV MHHDLE MHHDV0 MHHE4X MHHE52 MHHEA5 MHHEA7 MHHEMY MHHEN8 MHHEPE MHHERJ MHHERK MHHERL MHHERM MHHERR MHHERW MHHERX MHHHK3 MHHHKE MHHHT0 MHHJ39 MHHJ4X MHHPR0 MHHR48 MHHR49 MHHR4A MHHRR6 MHHRTY MHHRWW MHHT42 MHHT43 MHJ34E MHJ37R MHJ38W MHJ39M MHJ3JL MHJ3JM MHJ3JN MHJ3JP MHJ4ML MHJ4MM MHJ4YL MHJ4YM MHJ56K MHJDWA MHJE03 MHJE04 MHJE14 MHJE1W MHJE6V MHJE6VX1 MHJE6W MHJEE6 MHJEPX MHJH11 MHJH44 MHJH77 MHJH7E MHJH8V MHN1VT MHN1XE MHN1XJ MHN1XX MHNKHW MHNKJP MHNKJR MHNKJT MHNKRY MHNKV6 MHNKVX MHNKVY MHNKVYX1 MHNKW0 MHNKX8 MHNL59 MHNL5D MHNL5H MHNLWT MHNLWY MHNM03 MHNM24 MHNM25 MHNM3Y MHNM40 MHNM41 MHNN0P MHNN18 MHNN1J MHNN67 MHNN79 MHNN7J MHNN8K MHNN8L MHNN8M MHNNJV MHNNJW MHNNJX MHP1V7 MHP1V8 MHP1V9 MHP244 MHP245 MHP246 MHP247 MHP278 MHP279 MHP27D MHP298 MHP29E MHP29H MHP29J MHP29K MHP29L MHP29M MHP29N MHP29P MHP29R MHP29W MHP29X MHP29Y MHP2A0 MHP2A1 MHP2A2 MHP2A3 MHP2A4 MHP2A5 MHP2A6 MHPM2V MHPM3Y MJET31 MJET4E MJH50R MJH50T MJH50V MJH6XD MJH6Y0 MJH6Y1 MJH7JV MJHAAJ MJHAAK MJHAAL MJHAAX MJHAH3 MJHAMD MJHAT4 MJHAT8 MJHAT9 MJHATA MJHAYD MJHAYJ MJHD74 MJHD76 MJHD77 MJHDHH MJHDHJ MJHDHK MJHDLE MJHDLX MJHDLY MJHDM0 MJHDPK MJHDT4 MJHDWX MJHE0J MJHE0P MJHE98 MJHEE6 MJHEEA MJHEER MJHJK7 MJHK07 MJHK08 MJHK09 MJHK29 MJHK2A MJHK4E MJHK72 MJHK8L MJHKH5 MJHN07 MJHN56 MJHN57 MJHN75 MJHN76 MJHNDR MJHNER MJHNKE MJHNLH MJHNP1 MJHNP3 MJHNP4 MJHNW0 MJHNW1 MJHNW3 MJHP2D MJHP52 MJHP7M MJHT9V MJHT9W MJNRVW MJNTA1 MJNV1D MJNV4E MJNVKE MJNVPE MJNVYP MJNW57 MJNWK2 MJNYER MJP0EL MJP0TV MJP1N7 MJP20J MJP24X MJP2P4 MJP2PM MJP2TM MJP34K MJP3K9 MJP3RD MJP43A MJP4A7 MJP4YP MJP5DJ MJP5VV MJP6LT MJP73W MJP74M MJP7AE MJP7ND MJP7VA MJP832 MJP90E MJP90W MJP9EL MJPA65 MJPD50 MJPDJJ MJPED4 MJPEVT MJPEVW MJPHWJ MJPJME MJPK4X MJPKA9 MJPKHL MJPKJM MJPL8E MJPLKL MJPM5E MJPM8R MJPM9D MJPMT2 MJPN4N MJPNV5 MJPNV9 MJPP0V MJPP2T MJPPPK MJPPR2 MJPR53 MJPRDX MJPRRH MJPT4P MJPTJJ MJPV89 MJPW5J MJPWDL MJPXNP N1XMNA N1XMNAX1 N1XMNAX2 N24MRD N4KMNA N4KMNAX1 N4LMNA N4MMNA N4MMNAX1 N4XMME N5KMDD N5KMDDX1 N5LMDD N6MMDE N7NMJA N7PMJA NA1MRD NA4MME NA8MME NE2MED NE2MEDX1 NE7MRD NKRMAE NKTMAE NKVMAE NLJMAE NN1MDE NN2MDE NN3MDE NNAMRD NNEMRD NNLMJE NPHMKE NPJMKE NPMMKE NPTMED NPXMED NR3MHE NW5MDE NXKMKD NXXMKE NYXMKD NYYMKD P0NMLE P0PMKD P0PMLE P0RMLE P0TMKD P32MKE P3HMJE P3JMJE P3KMJE P3TMHD P3VMEA P3WMEA P8MMED P8TMKE P8TMKEX1 P93MDD PE7MPD PEHMMD PEJMHD PJJMHD PJKMHD PJMMHD PJNMHD PJRMHD PKMMEA PMAMHD PMDMHD
• Recalling Firm/ Manufacturer: Howmedica Osteonics Corp.; 325 Corporate Dr; Mahwah NJ 07430-2006
• For Additional Information Contact: Eric Petschler; 201-831-5000
• Manufacturer Reason for Recall: The recalling firm has received a higher than expected number of complaints documenting femoral head/hip stem disassociation for certain sizes of femoral heads manufactured prior to March 4, 2011.
• FDA Determined Cause: Process control
• Action: On May 22, 2018, Stryker issued a Product Safety Notification to its affected customers. The letter explained the issue and instructed customers to do the following: Follow-up Patients implanted with the Products should continue to be followed per the normal protocol established by his/her surgeon(s). There are no recommended changes to the frequency of the standard follow-up care protocol. Required actions 1. Hospitals/Surgeons: Please inform product users of this notification and forward this notice to all those individuals who need to be aware within your organization. Please also complete and sign the enclosed Business Reply Form and fax a copy to 888-861-8582 or email to Stericycle at strykerortho5940@stencycle com. Product is not required to be returned as part of this notification. if you have any questions, feel free to contact the firm at (201) 831-5151.
• Distribution: Distributed nationwide. Foreign distribution to Australia, Canada, Chile, China, Brazil, France, Germany, India, Italy, Japan, Malaysia, Netherlands, New Zealand, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, and United Kingdom.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JDI and Original Applicant = HOWMEDICA OSTEONICS CORP.