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-2296-2018
• 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, Catalog No. 6260-9-140
• Code Information: Lots 201MJD 20RMJD 20TMED 20XMLE 211MJD 217MKD 21AMKD 21DMKD 21KMJD 21LMKD 21LMKDX1 21VMKD 21WMKD 21WMKDX1 21XMKD 21YMKD 223MAE 234MKE 241MJD 26XMHE 26YMHE 270MHE 280MAE 28TMTD 297MTD 2DDMKE 2DJMJD 2HKMKE 2HNMKE 2JPMKE 2JVMKE 2KKMJD 2MMMAE 2MPMAE 2MRMAE 2MTMAE 2NAMKE 2VDMAE 2VMMAE 2W6MAE 2W6MJD 2W7MJD 2W8MAE 2WAMJD 2WPMHE 2X5MHE 2XTMAE 2XVMAE 301MHE 30PMAE 30XMJD 30YMJD 315MJD 31NMLE 31PMLE 31RMLE 31TMLE 338MAE 33PMED 33RMED 33TMED 33VMED 33WMED 33XMED 343MED 344MED 345MED 361MRA 361MRAX1 362MRA 8E3MMA 8E3MMAX1 8E4MMA 8E6MMA 8E8MMA 8E8MMAX1 8E9MMA 8ERMMA 8H8MPD 8J8MMA 8L6MPD 8NJMMA 8NJMMAX1 8PLMRA 8PMMRA 8PNMRA 8PNMRAX1 8PTMPD 8PXMPD 8T3MMA 8VPMMA 91AMPE 925MLD 926MLD 934MMA 934MMAX1 93DMMA 953MPA 954MPA 954MPAX1 976MMA 977MMA 978MMA 979MMA 97AMMA 97DMMA 97PMTA 97PMTAX1 97RMTA 97TMTA 97VMTA 97WMTA 99EMPE 99HMPE 9ADMME 9AEMME 9AHMME 9AJMME 9AVMPE 9D5MPE 9DMMPE 9DNMMA 9DPMMA 9DPMMAX1 9DRMPE 9E8MPE 9E9MMA 9E9MMAX1 9E9MMAX1X1 9EEMMA 9EHMMA 9EHMMAX1 9H7MPE 9H9MPE 9L7MPE 9LPMPE 9TJMJD 9TJMJDX1 9TJMJDX2 9V8MJD JH9MJE JHAMJE JHDMJE JHEMJE JHNMPD JHRMED JHRMEDX1 JHVMAE JHWMAE JHXMAE JHYMAE JJ9MLE JKNMDD JKNMDDX1 JKPMAE JKRMAE JLKMDD JLLMDD JLMMDD JLPMDD JLRMDD JLRMDDX1 JLTMDD JLTMDDX1 JLVMDD JLVMDDX1 JMXMHE JN8MPD JN9MPD JNXMED JPRMPD JT2MED JTTMED JVYMED JWXMME JWYMED JWYMEDX1 JX0MME JX1MME JX2MME JX3MED JX4MED JY5MKD JY9MPD K0JMED K2AMHD K5MMJE K66MHD K68MHD K68MHDX1 K78MED K78MEDX1 K7AMED K7DMED K7EMED K7EMJE K7HMED K7HMEDX1 K7HMJE K7JMJE K7KMJE K8WMHD K8XMHD K8XMHDX1 K8YMHD K8YMHDX1 K90MHD K91MHD K91MHDX1 KA1MLE MER718 MERDEP MERDER MERDH8 MERDH9 MERDHA MERDHD MERDHE MERDHEX1 MERDHH MERE2V MERED2 MEREP5 MEREP6 MERHR9 MERHVX MERK77 MERK79 MERK7A MET56M MET56MX1 MET5JX MET5JXX1 MET5JY MET5K0 MET635 MET636 MET637 MET638 MET7DK MET7DKX1 MET7K0 MET7K8 MET7KH MET7KM MET7L9 MET7LJ MET7LM MET7LW MET9Y2 MET9Y3 MET9Y4 METAE4 METAML METARE METATX METATXX1 METATY METATYX1 METAV0 METAVY METAW5 METAWH METAYE METD13 METD13X1 METD20 METD33 METD37 METE6J METE6T METE81 METE82 METE83 METE84 METJMA METJMD METJME METJMEX1 METJMH MHEX2A MHEX30 MHEX3K MHEX3L MHEXD7 MHEXJJ MHEXK3 MHEXNA MHEXVV MHEY78 MHEY8R MHEY8W MHEY8WX1 MHEYDJ MHH0D3 MHH18L MHH1AK MHH1L4 MHH1VR MHH1VRX1 MHH1VRX2 MHH1VT MHH565 MHH5HL MHH5HLX1 MHH5HM MHH5VW MHH629 MHH65D MHH65T MHHHKW MHHJ1N MHHJ56 MHHJYA MHHK3L MHHK5N MHHKH8 MHHKM3 MHHKM8 MHHKML MHHKN8 MHHKT2 MHHKVW MHHKYP MHHL1R MHHL61 MHHL7K MHHL8T MHHMPD MHHPPX MHHPXW MHHPYA MHHPYL MHHR14 MHHR45 MHHR46 MHHR47 MHHRK6 MHHRK8 MHHRKA MHHRR5 MHHRT2 MHHRTX MHHRV6 MHHRWV MHHT44 MHHT45 MHHT46 MHHTH5 MHHTH6 MHME90 MHME96 MHMEM2 MHMEM3 MHMEM5 MHMEM6 MHMH4K MHMH4L MHMH5P MHMH5R MHMH5RX1 MHMH72 MHMH8A MHMH8E MHMH8H MHMH8J MHMHHJ MHMHHK MHMHHL MHMHHM MHMHJY MHMJ79 MHMJ7E MHMJ8K MHMJ8M MHMJ93 MHMJ94 MHMJ9N MHMJA8 MHMJA9 MHMJAA MHMJAD MHMJEJ MHMJEJX1 MHMJEK MHMJEM MHMJEN MHMM6M MHMN4J MHMNEX MHMNM2 MHN5A4 MHN5DD MHN5DR MHN5E1 MHN5EM MHN5HH MHN5HJ MHN5HK MHN5HL MHN5NR MHN5NT MHN5NV MHN5NW MHN61R MHN6PA MHN6PT MHN6R3 MHN6R5 MHN73A MHN73D MHN73E MHN73J MHN7EL MHN7EP MHN7ER MHN7ET MHN7YJ MHN7YK MHN7YW MHT9EW MHT9EX MHT9EY MHT9H0 MHT9H2 MHTA8N MHTA8P MHTA8V MHTA8W MHTA9K MHTA9L MHTAA2 MHTAA3 MHTAA4 MHTAA5 MHTDP1 MHTDX4 MHTE75 MHTE94 MHTEE3 MHTEE8 MHTEHJ MHTEKN MHTEPK MHTEX0 MHTEX5 MHTEYY MHTH0L MHTH0M MHTH16 MJ5MKE MJA521 MJA522 MJA523 MJA524 MJA525 MJA526 MJA527 MJA528 MJA529 MJA63N MJA63P MJA645 MJA646 MJA69R MJA69T MJA69V MJA69W MJA6DV MJA6DW MJA6DX MJA6DY MJA6M5 MJA6M6 MJA6M7 MJA6M8 MJA6M9 MJAT16 MJAT17 MJAT18 MJAT19 MJAT8N MJATDP MJATE5 MJAV2V MJAV2W MJAV2X MJAV2Y MJAVJE MJAW06 MJK923 MJK9EW MJK9EY MJK9H0 MJK9H1 MJK9NP MJK9NR MJK9R8 MJK9R9 MJK9RA MJKA07 MJKA08 MJKA09 MJKAM9 MJKAMA MJKAVX MJKAW0 MJKAW1 MJKAW2 MJKDNT MJKDNV MJKDNW MJKDNX MJKHRW MJKHRX MJKHV7 MJKHW1 MJKHX1 MJKJ06 MJKJ31 MJKJ64 MJKJ88 MJKJEE MJKJPL MJKJPM MJKJPN MJKJPR MJKJT3 MJKJV6 MJKJV7 MJKJV9 MJKJVA MJKJX5 MJKK1P MJKK31 MJKK3X MJKK80 MJKKAK MJKKHW MJKKK9 MJKKKR MJKKKT MJKM08 MJKM09 MJKM0A MJKM0E MJKMEK MJKMEL MJKMEM MJKMEN MJKMPP MJKMPT MJKMPW MJKMR2 MJL0X5 MJL15K MJL1AR MJL2T9 MJL33N MJL36J MJNTH3 MJNTY5 MJNVTK MJNVWJ MJNWEV MJNX70 MJNXPN MJNXTJ MJNXYJ MJNY53 MJNY81 MJP06M MJP088 MJP0H9 MJP0N0 MJP0PD MJP0PY MJP19E MJP1D0 MJP24V MJP25P MJP2P6 MJP2T8 MJP3JL MJP3NA MJP44K MJP59V MJP5HY MJP5MD MJP5RT MJP5V1 MJP6HL MJP71D MJP76M MJP7LR MJP7W7 MJP7WA MJP7XM MJP80T MJP819 MJP81E MJP8L3 MJP8M5 MJP8N2 MJP8TL MJP9EN MJP9KY MJP9P2 MJPA2A MJPA62 MJPATD MJPATV MJPD1L MJPDM0 MJPDRL MJPE3N MJPE67 MJPE98 MJPED5 MJPELA MJPHN4 MJPHRA MJPJ5Y MJPJ6X MJPJ94 MJPJRJ MJPK8L MJPKV2 MJPLMT MJPLV7 MKAXV6 MKAY86 MKAYD3 MKD00V MKD066 MKD0WA MKD1JY MKD1N6 MKD20E MKD226 MKD299 MKD2R7 MKD3NV MKD3PX MKD3T9 MKD48X MKD4J8 MKD4PM MKD56A MKD58W MKD5DV MKD5JE MKD5LK MKD6E2 MKD6E5 MKD709 MKD71T MKD8A2 MKD8M5 MKD8MW MKD8P9 MKD8X8 MKD9D4 MKD9KN MKDA48 MKDA5P MKDA5Y MKDALD MKDALY MKDANV MKDAP4 MKDAYJ MKDJP8 MKDKMM MKDL3D MKDL3E MKDL64 MKDMLE MKDN51 MKDN5V MKDPH1 MKDPH2 MKDPXY MKDRAJ MKDT49 MKDT6T MKDTRP MKDWX1 MKDX3P MKDYAV MKE15P MKE18V MKE2A0 MKE2L2 MKE3E4 MKE3R4 MKE43X MKE456 MKE54L MKE7LY W0DMNE W0KMNE W44MKD W44MKDX1 W49MJE W4WMKA W58MNE W7DMJE W82MJE W85MJE W8LMJE WAHMAD WAJMAD WARMAD WARMADX1 WATMAD WAVMAD WAWMAD WAXMAD WD0MAD WD0MHE WD1MAD WD1MHE WD2MAD WD2MHE WD3MAD WD3MADX1 WD3MHE WD5MAD WD9MAD WDAMAD WDDMAD WDWMAD WHJMKD WJNMME WJTMME WJWMME WJYMME WL9MNE WM4MKA WM4MKAX1 WN8MNE WPEMKD WVAMKA WVDMKA WVDMKAX1 WVEMKA WVHMKA WVHMKAX1 WW6MME WWPMME WWXMKD WWXMKDX1 WWXMKDX1X1 WWYMKD WX4MEE WX6MEE WX7MEE WX8MEE X2KMKD X2MMKD X3HMNE X47MKD X4EMKD X4MMKD X4MMKDX1 X4NMJE X52MKD X5LMKD X5NMHE 362MRAX1 363MRA 363MRAX1 364MRA 36AMAE 39PMAE 3AVMPA 3AVMPAX1 3AWMPA 3DYMAE 3L4MHE 3LYMEE 3M0MEE 3M1MEE 3M2MEE 3PNMLE 3PPMLE 3TLMHE 3V8MLE 3V8MLEX1 3VDMLE 3WLMHE 415MLE 44MMHE 484MPD 48DMRD 48YMPD 490MPD 4DNMED 4DPMED 4DRMED 4DTMED 4DTMEDX1 4DTMRD 4DVMED 4DYMPD 4E0MPD 4E1MPD 4H8MEE 4KAMRD 4NRMRD 4RKMTD 4RMMTD 4RPMTD 4RTMTD 4RVMTD 4VMMRD 4W7MAE 4W8MAE 4W9MAE 4WAMAE 4WEMEE 4WHMEE 4WJMEE 4WKMEE 4WPMRD 4YVMME 542MAE 552MTA 557MTA 55AMTA 55AMTAX1 55DMTA 55MMAD 55PMAD 55RMAD 55TMAD 55VMAD 55WMAD 56MMRD 9V8MJDX1 9V8MJDX1X1 9X8MPA 9X9MPA 9XAMPA A1HMME A1KMME A1LMEE A1LMME A1MMEE A1MMME A1NMEE A1PMEE A2AMMD A3EMPA A3LMPA A43MMD A49MEE A58MEE A5MMME A5NMLD A5NMLDX1 A5RMLD A6VMEE A96MEE AD2MJD AH6MJD AH6MJDX1 AJVMJE AMPMHE AN0MHE ARHMJD ARHMJDX1 ARHMJDX1X1 AT0MJD AT5MJD AT5MJDX1 AT6MKD AT6MKDX1 AT7MKD AT9MJD AT9MJDX1 ATKMJD AW2MKD AW3MKD AWYMKD AX0MKD AX8MKD D1MMHE D1NMHE D37MLD D3DMHE D3DMLD D3EMLD D3EMLDX1 D3NMLD D71MND D72MND D73MND D9KMEE D9LMEE D9MMEE D9NMEE DHRMHD DMAMND DMDMND DMEMND DN0MDE DN1MDE DN2MDE KAAMHD KAXMHD KD0MHD KJKMLE KK6MLE KKLMLE KKRMKD KKXMKD KL0MKD KMHMKD KMJMKD KMKMKD KPKMKD KPLMKD KPNMKD KPPMKD KR5MPA KR8MPA KR8MPAX1 KR9MPA KRAMPA KV6MHE KWEMHE KX5MHE KY3MNA KY4MNA KY4MNAX1 KY5MNA KY5MNAX1 KY8MNA KY9MNA KY9MNAX1 KYPMPA KYRMPA L01MJE L02MPA L1DMHE L1RMNA L1RMNAX1 L1TMNA L2JMLE L2PMNA L2RMNA L2TMNA L2VMNA L2WMNA L4WMHE L64MHE L69MJE L6AMJE L6DMJE L6EMJE L73MND L7KMND L7YMND L85MND L8DMND L96MNA L96MNAX1 L9VMTA L9VMTAX1 LA0MTA LA1MTA LA8MTA LAEMTA LAJMPA LAJMPAX1 LD2MPA LD2MPAX1 LEAMRA METJMJ METJMK METJML METJMM METKJL METKK3 METKK4 METKK8 METKK9 METKLM METKMD METLL0 METM60 METM6X METMJH MHA68V MHA69X MHA6KP MHA6KR MHA71J MHA71JX1 MHA71X MHA72L MHA74X MHA751 MHA752 MHA753 MHA9DV MHA9DX MHA9DY MHA9E1 MHA9E3 MHA9EE MHA9EJ MHA9EP MHA9EW MHA9H0 MHA9H0X1 MHAKK6 MHAKVK MHAKW2 MHAL00 MHAL01 MHAL3D MHAL76 MHAL78 MHAL79 MHALLY MHALMD MHAN2R MHAN2T MHAN43 MHAN4Y MHAN52 MHAN5M MHAN5T MHAN6K MHAN6KX1 MHAN94 MHAN9N MHAN9P MHANA9 MHANAE MHDJ2J MHDMM5 MHDMM5X1 MHDMM6 MHDMM7 MHDMM8 MHDMMR MHHTLY MHHTNK MHHTR7 MHHTT3 MHHTT7 MHHTVV MHHTWD MHHTWE MHHTWEX1 MHJ0T3 MHJ0V5 MHJ0V6 MHJ0VY MHJ0WN MHJ589 MHJ596 MHJ59V MHJ5AR MHJ5M3 MHJ5R8 MHJ5V9 MHJ61H MHJ655 MHJ6DD MHJ6E8 MHJ6E9 MHJ6EY MHJ6H3 MHJ6HP MHJ6KN MHJMKE MHJRDT MHJRDW MHJRDX MHJRW4 MHJT19 MHJT25 MHK1Y1 MHK219 MHK22E MHK22J MHK252 MHK253 MHK2EY MHK2LY MHK2ML MHK2N2 MHK2N4 MHK2NA MHK2ND MHK2P4 MHK2VW MHK2VX MHK2VY MHK35P MHK35R MHK3AD MHK3EP MHK3YY MHK404 MHK4D1 MHK4D6 MHK4X0 MHK545 MHK54L MHK54N MHK5AA MHK5E5 MHK5J4 MHK5JT MHN7YY MHN85V MHN85W MHN85X MHN85Y MHN8K8 MHN923 MHN925 MHN926 MHN93A MHNH8K MHNHA9 MHNHAA MHNHAD MHNHHH MHNHHK MHNHHL MHNHHM MHNHVM MHNHVN MHNJ6X MHNJ6Y MHNJ70 MHNJ72 MHNJ8R MHNJ8T MHNJAW MHNJAX MHNJAY MHNJD0 MHNJJ3 MHNJJ4 MHNJJ5 MHNJJ6 MHNK9R MHNKE9 MHNKEA MHNKHV MHNMKE MHNN7E MHNN8D MHNN8E MHNN8H MHNN8J MHNPM9 MHNPMA MHNPPM MHNPPP MHNR3E MHNR3H MHNRE7 MHNRE8 MHNRE9 MHNREA MHNRNH MHNRNJ MHNRNK MHNRNL MHNTE9 MHNTEE MHNTMD MHNTMN MHNTMW MHNTNT MHNTPM MHNTPN MHNTPP MHNTPR MHNTPX MHNV2D MJAW35 MJAW42 MJAW4T MJD1JK MJD1MH MJD1NV MJD1RK MJD1TT MJD1X7 MJD22A MJD2E3 MJD2E4 MJD2EM MJD2EN MJD2H6 MJD2H7 MJD2J1 MJD2J2 MJD2JD MJD2JL MJD2KP MJD2NN MJD2R4 MJD2X5 MJD2Y4 MJD31P MJD3M3 MJD3M5 MJD3MH MJD3N0 MJD3PW MJD3R4 MJD3TV MJD3XA MJD410 MJD453 MJD47X MJD48N MJD4V9 MJD4VA MJD4VR MJD4WP MJD4Y3 MJD50X MJD52E MJD54M MJD579 MJD59J MJD5EM MJD5KP MJD68Y MJD6D9 MJD6NL MJD6TJ MJD6WT MJD76A MJD7M3 MJD7M4 MJD7M5 MJD7P5 MJDHAH MJDHAJ MJDHAK MJDHAL MJDHJ8 MJDHM4 MJDHRN MJDHXH MJDHY6 MJDJ1N MJL39T MJL3HA MJL3JN MJL3T2 MJL48X MJL4L2 MJL4N5 MJL5H0 MJL5J0 MJL5VY MJL73X MJL748 MJL7EX MJL7WE MJL7XJ MJL9E1 MJL9E2 MJL9E3 MJL9PV MJL9T2 MJLA8K MJLA8L MJLA8M MJLA9H MJLAA1 MJLAA2 MJLAA3 MJLAA4 MJLAHN MJLALN MJLALP MJLALR MJLALT MJLAY0 MJLD67 MJLEK6 MJLELP MJLEXT MJLHRM MJLHVT MJLJDD MJLK78 MJLK7Y MJLKJ9 MJLKLM MJLKTD MJLL02 MJLM2R MJLM5W MJLM6P MJLM8E MJLN6J MJLNMA MJLNPE MJLNXW MJLP14 MJLPK4 MJLR8A MJLRDA MJLRY7 MJLTK1 MJLV53 MJLV6T MJLV83 MJLVRA MJLVVD MJLVX7 MJLW8D MJLWD6 MJLWJD MJPMLD MJPN5J MJPNHJ MJPNKJ MJPNNK MJPP1N MJPP37 MJPP7N MJPPDW MJPR57 MJPR8H MJPR9Y MJPRD8 MJPT5R MJPT8W MJPV99 MJPVE4 MJPVK5 MJPVV3 MJPVYD MJPWAW MJPWD5 MJPWEE MJPWK6 MJPWKX MJPWL3 MJPX56 MJPXAM MJPY34 MJPY7X MJPY9P MJPYWP MJR05N MJR09T MJR0EE MJR1XH MJR5N0 MJR5PT MJR62W MJR6R9 MJR6V6 MJR7L3 MJR7R1 MJR9E2 MJR9HA MJR9K6 MJR9W7 MJRAEN MJRAJ2 MJRDHT MJRE79 MJRHHL MJRHT8 MJRJ0H MJRJ51 MJRJ8N MJRJ8P MJRL4D MJRLJJ MJRM11 MJRM4E MJRN1X MJRN5L MJRN8D MJRNHJ MJRPK3 MJRPV0 MJRR4J MJRT1A MJRTNM MKE8R8 MKE8TL MKE9V2 MKEAT1 MKEPP4 MKER2J MKERTM MKERTN MKEWEK MKJMED MR4MED MR4MEDX1 MV2MMA MV3MMA MV4MMA MV4MMAX1 MV4MMAX1X1 MV6MMA MVKMMA MVKMMAX1 MVRMDE MWKMEE MX4MEE MX5MED MX5MEDX1 MXVMMA MXVMMAX1 N32MEE N35MHE N58MHE N5XMMA N61MEE N85MHE N9NMHE NE1MDE NE2MDE NE3MDE NJJMEE NL1MAE NLKMAE NLXMEE NM1MDE NPPMAE NT3MEE NT4MEE NTPMDE NTRMDE NWAMDE P1YMKD P1YMKDX1 P46MKD P46MKDX1 P48MKD P48MKDX1 P5MMAE P8XMDD P8YMDD P90MDD P91MDD P9DMKD PHNMDE PNWMAE PPYMMA PPYMMAX2 PR0MMA PR1MMA PR1MMAX1 PRLMAE PWTMJE PWVMAE X63MNE X64MKD X64MNE X65MNE XAVMKD XENMHE XENMHEX1 XEPMHE XERMHE XETMHE XHWMJE XHXMJE XHYMJE XJ0MJE XLXMJE XLYMJE XM0MJE XM1MJE XYXMKD Y4RMJE Y6YMKD Y7PMKD Y8TMJE YAEMJE YDYMKD YE0MKD YH6MJE YHYMKD YM8MJE YMNMJE YMPMJE 00NMLE 00PMLE 00TMLE 00VMLE 033MRA 033MRAX1 034MRA 036MRA 037MRA 03WMEE 05JMEE 0DXMAE 0E0MAE 0KAMLE 0KDMLE 0M5MEE 0MWMPAX1 0MWMPAX1X1 0T4MKD 0T4MKDX1 0T5MKD 0T5MKDX1 0T6MKD 0T7MKD 0T8MKD 57EMPD 57JMPD 57TMTA 57XMME 57YMME 580MME 580MTA 580MTAX1 584MTA 584MTAX1 5AEMPA 5AEMPAX1 5AHMPA 5AJMPA 5AJMPAX1 5PTMRD 5THMRD 5WAMRD 5WTMNE 5YEMNE 60HMNE 60WMNE 60XMNE 618MNE 61DMNE 625MNE 64DMAD 64EMAD 64HMAD 64JMAD 64KMAD 64LMAD 69KMNE 6AAMTD 6ALMTD 6E0MND 6E1MND 6E2MND 6E3MND 6E5MND 6E6MND 6H7MND 6JAMNE 6KTMRD 6LLMNE 6NXMMD 6NYMMD 6P0MMD 6P1MMD 6TVMMD 6V7MMD 6W5MLD 6W6MLD 6XXMMD 71NMMD 753MTD 76JMAD 76KMAD 76LMAD 76MMAD 76NMAD 76PMAD 76PMADX1 770MTD 774MTD 778MRD 779MRD 77RMNE 77XMTA 77YMTA DN3MDE DPNMHE DPPMHE DPRMHE DR2MHD DRWMJE DRWMJEX1 DV5MHD DVVMJE DX2MJE DX9MHD DYRMHD E14MHD E17MHD E18MHD E23MHD E23MHDX1 E23MJE E23MJEX1 E24MHD E25MHD E2VMHD E2YMHD E5DMRD E5EMRD E73MRD E74MRD E7EMNE E7JMJE E83MNE E85MNE E8WMNE E90MJE E9EMND E9HMND E9JMND E9KMND E9LMND E9MMND EA2MEE EA3MEE EA4MEE EA5MEE EA8MTD EA9MTD EAAMTD ED9MME ED9MTD EDAMTD EDDMTD EE2MME EH3MEE EH4MEE EH5MEE EH6MEE EJ3MRD EK7MMA EM8MNE EM9MNE EMAMNE EMDMNE EN1MLD EN2MLD EN4MLD EV0MPA EV1MPA EV6MPA EV7MPA H07MLE H08MLE LEKMRA LEVMNA LEWMNA LJ4MRAX1 LK7MLE LLVMLE LNEMLE LNPMLE LRYMRA LT9MDD LT9MDDX1 LTAMDD LTDMDD LX9MRA LXXMNA LXXMNAX1 LXYMNA LXYMNAX1 LY0MKD LY0MNA LY1MNA M2PMRA M2PMRAX1 M69MMA M6DMRA M6DMRAX1 M6EMRA M82MED M82MKE M9VMED MA0MPD MA1MPD MA2MPD MA2MPDX1 MANMDD MAVMDD MD3MDD MD6MKE MD7MKE MDAMPD MDKMPD MDTMKE MDXMKE ME5MNA ME5MNAX1 MELMDE MEMMDE MENMDE MEP9NA MEP9T2 MEP9WW MEP9YH MEPA3R MEPAET MEPAETX1 MEPAP4 MEPATJ MEPATK MEPAV1 MEPAWD MEPAWH MEPD8K MEPD8P MEPDEA MEPDEAX1 MEPH79 MEPH7A MEPH82 MEPH84 MEPH8T MHDMMT MHDMMV MHDMMW MHDNN7 MHDNN8 MHDNN9 MHDNNA MHDR12 MHDR7Y MHDR91 MHDRVK MHDRVL MHDRVM MHDT73 MHDT7A MHDT7AX1 MHDT7D MHDT82 MHDT82X1 MHDT8E MHDT8L MHDT8V MHDT8VX1 MHDT93 MHDT9W MHDTDN MHDTDP MHDTDPX1 MHDTDR MHDTDT MHDTDTX1 MHDTPH MHDTPJ MHDTPK MHDTPL MHDV03 MHDV0Y MHDV10 MHDV8R MHDVE3 MHDVE4 MHDVE5 MHDVEW MHDVJ0 MHDVJ1 MHDVL3 MHDVL7 MHDVL8 MHDVLD MHDVM0 MHDVM4 MHDVM6 MHDVRK MHDVRL MHDVRM MHDVRN MHDVRR MHDVRV MHDWWE MHDWX1 MHDWXH MHDWXT MHDY0M MHE95E MHEK1N MHEK1P MHEK3M MHEK3MX1 MHEK61 MHEK61X1 MHK67X MHK680 MHK681 MHK6TE MHK704 MHK70Y MHK710 MHK713 MHK718 MHK71L MHK769 MHK78X MHK78Y MHK7K4 MHK7V7 MHK7V8 MHK7WH MHK7WJ MHK7XH MHK7XJ MHL15N MHL15W MHL15X MHL15Y MHL160 MHL161 MHL22L MHL22M MHL22N MHL22P MHL22R MHL22T MHL22V MHL22W MHL22X MHL39N MHL3D2 MHL3M4 MHL3Y7 MHL404 MHL40T MHL412 MHL41M MHL46L MHL46M MHL46N MHL46R MHL46T MHL46W MHL59A MHL59E MHL59J MHL5ND MHL5W4 MHL5X1 MHL614 MHL636 MHL63K MHL63V MHL63Y MHL64V MHL67R MHL694 MHL6AW MHL6DR MHL6EN MHL6TD MHL6WH MHL707 MHL709 MHNV4H MHNV4J MHNV4K MHNV4L MHPAPY MHPAR0 MHPAR1 MHPDDX MHPDDY MHPDE0 MHPDE1 MHPE6H MHPE6J MHPE6K MHPE6L MHPEKY MHPEL1 MHPEL2 MHPEL3 MHPH4T MHPH4V MHPH4W MHPH4X MHPHDJ MHPHDN MHPHDT MHPHDX MHPHDY MHPHE0 MHPHE1 MHPHE2 MHPTR6 MHPTR8 MHPTR9 MHPTRA MHPTTW MHPTTY MHPTV1 MHPTV2 MHPVJE MHPVJH MHPVJJ MHPVJK MHPVVR MHPVVT MHPVVV MHPVVW MHPWV5 MHPWV6 MHPWV7 MHPWV8 MHR13T MHR14T MHR154 MHR157 MHR159 MHR3TK MHR3TL MHR3TM MHR3TN MHR3TR MHR3TV MHR3TW MHR3TX MHR3TY MHR9YM MHR9YN MHR9YP MHR9YR MHRAAP MJDJM9 MJDJMA MJDJMD MJE83L MJED4P MJED74 MJED87 MJED98 MJEDHD MJEDXE MJEDXH MJEE5T MJEE94 MJEEJ5 MJEEL3 MJEER3 MJEET8 MJEHAA MJEHAT MJEHD5 MJEHK7 MJEHTD MJEHW2 MJEHWJ MJEJ24 MJEJ4V MJEJKW MJEJM0 MJEJRK MJEJWK MJEK0L MJEK22 MJEKPT MJEKRV MJEKYX MJEL56 MJEL7D MJEL8X MJELEK MJELMM MJELMN MJELMP MJELMT MJELXT MJELXV MJEM3A MJHDJH MJHDJJ MJHDM3 MJHDNX MJHDT3 MJHDV0 MJHDV9 MJHDYX MJHE6N MJHE8P MJHK1K MJHK1N MJHK1P MJHK1T MJHK27 MJHK28 MJHK45 MJHK6Y MJHKJP MJHMH4 MJHMJD MJHMJN MJHP2E MJHP5D MJLWYW MJLXV2 MJLYP9 MJM04Y MJM06D MJM097 MJM0HY MJM171 MJM1N6 MJM1PT MJM2EH MJM2H9 MJM2HD MJM2HM MJM30N MJM406 MJM436 MJM442 MJM4H6 MJM4XJ MJM59N MJM5AL MJM5TK MJM5TL MJM6KK MJM6MW MJM721 MJM740 MJM76W MJM7JW MJM7M0 MJM870 MJM8DY MJM96L MJM9E0 MJM9T1 MJM9TM MJM9TY MJM9YK MJMA0H MJMA8T MJMATM MJMATN MJMD3H MJMD4H MJMDD6 MJMDDM MJMDDN MJMDTL MJME5R MJMEJ5 MJMHTH MJMJD8 MJMK8X MJMKHH MJMKXD MJMM2R MJMM6W MJMMTW MJMNH2 MJMNKY MJMNX4 MJMP7H MJMP89 MJMPVH MJMR9T MJMRL5 MJMTHW MJMTMP MJMTW7 MJRVHL MJRVYJ MJRWRH MJRXP1 MJRXW5 MJRYJJ MJRYVT MJT0EH MJT231 MJT2X4 MJT2XY MJT300 MJT308 MJT3KM MJT3R4 MJT465 MJT4LT MJT58K MJT5KA MJT5KY MJT69W MJT6X0 MJT73R MJT77D MJT7RH MJT91E MJT91H MJTA7N MJTD06 MJTD44 MJTD70 MJTD96 MJTDEH MJTDYJ MJTE9A MJTH43 MJTH9E MJTHAP MJTJ4R MJTJL2 MJTK6V MJTL6R MJTL7V MJTL80 MJTL9D MJTLKY MJTN62 MJTNHJ MJTNKV MJTP2P MJTPN2 MJTPY2 MJTR51 MJTRN8 MJTRX7 MJTTHE MJTTYA MJTTYV MJTV12 MJTV87 MJTV8X MJTVTL MJTVWJ MJTWWM MJTX3W MJTY2X MJTY80 MJTYDL MJTYRK MKA0KT PWVMJE PWWMJE PWXMJE PWYMJE PX0MJE PX1MJE PX2MJE R13MEE R14MEE R15MEE R16MEE R5JMAE R72MAE R7LMAE RPEMAE RPKMAE RR2MPD RR4MPD RR5MPD RVJMPA RVKMPA RVLMPA RVLMPAX1 RWRMPD RWTMPD RWVMPD T04MAE T05MAE T06MAE T07MAE T24MJE T24MJEX1 T25MJE T29MJE T2AMJE T2DMJE T2EMJE T4JMJE T4MMJE T4PMJE T4WMJE T5LMJE T5NMJE T5RMJE T64MJE T7JMAE T86MJE T8PMDE T8TMAE T8TMDE T8VMDE T8WMDE TA4MAE TAAMJE TD8MJE THVMNE THWMNE THXMNE THYMNE TJ6MJE TJHMJE TL7MLE TL8MLE TL9MLE TLDMLE TLKMAE TPYMJE TTDMJE TWEMJD TWEMJDX1 0T8MKDX1 0TNMLE 0TXMMD 0TYMMD 0WAMMD 0WDMMD 0WDMMDX1 0WJMNE 0WLMMD 0WNMMD 0WNMMDX1 0X0MNE 0XJMNE 0XWMMD 0Y0MNE 0Y9MLE 0YAMLE 106MMD 10HMED 112MLE 113MLE 11TMKD 11TMKDX1 11VMKD 11VMMD 11WMKD 11YMLE 12RMPE 135MJD 139MKD 13AMKD 13AMKDX1 13DMJE 13DMKD 13DMKDX1 13EMKD 13EMKDX1 13HMKD 13JMKD 13JMKDX1 13KMKD 13KMKDX1 13LMED 13LMKD 13MMED 13NMED 13TMED 13TMNE 13XMED 140MED 142MED 148MNE 14KMPE 14RMJE 15PMLE 165MJE 18YMJE 19AMMD 1J3MTD 1J4MTD 1J6MTD 1J7MTD 1J8MTD 1JNMMD 1LKMMD 1T5MMD 1T8MMD 1VMMHE 1X5MMD 1YYMJD 780MTA 781MTA 781MTAX1 78TMNE 793MNE 79AMMD 7A6MTD 7D9MMD 7DAMDE 7DDMTD 7DMMJE 7EHMJE 7EJMDE 7H9MDE 7HXMJE 7J1MMD 7K8MJE 7LHMDE 7MEMDD 7MJMDD 7MJMJE 7MVMDD 7MYMDD 7N1MDD 7N6MDD 7N8MDD 7NAMHD 7NAMHDX1 7NDMHD 7NEMHD 7NEMHDX1 7NHMHD 7NHMHDX1 7NJMHD 7NNMMD 7NVMDD 7NVMDDX1 7RAMPA 7RAMPAX1 7TMMPA 7TPMMD 7TPMPA 7TPMPAX1 7TRMMD 7TTMMD 7TWMMD 7VXMJE 7X2MMD 7XYMPD 7Y1MMA 82NMPD 82WMPD 845MME 849MME 852MME 853MME 854MME 855MME 856MME 856MMEX1 858MME 862MMA 89VMPD 8ANMMA 8APMMA 8ARMMA 8E0MMA 8E1MLD 8E2MMA 8E2MMAX1 H0LMMA H0NMLE H0PMLE H4PMRA H4PMRAX1 H4RMRA H4RMRAX1 H4TMRA H6LMLD H6MMLD H6PMLD H8NMDD H93MDD H9TMPD HADMPD HAEMPD HD3MPD HD5MPD HDMMPD HE1MLD HE2MLD HE2MLDX1 HE3MLD HE4MLD HH3MME HH7MLE HHJMLE HHLMLE HHNMLE HJ0MDD HJ0MDDX1 HJHMDD HJHMDDX1 HJVMDD HMWMME HR2MME HR6MME HR8MME HRYMME HT0MME HT1MME HV6MHE HV7MHE HV8MHE HV8MRA HV9MHE HV9MRA HVAMRA HXPMLE J15MRD J1EMRD J1LMRD J20MRD J25MTA J26MRD J27MTA J28MTA J28MTAX1 J29MTA J2DMRD J2DMTA J2JMTA J2KMTA J36MRD J46MHE J70MHE J96MLE J99MLE J9DMLE JH0MHE MEPHV2 MEPHV3 MEPHV5 MEPJ6X MEPJ70 MEPJ7L MEPJ8H MEPJ8K MEPM70 MEPMDE MEPMLA MEPMPD MEPMRY MEPMT1 MEPMTX MEPMTXX1 MEPMV3 MEPNX6 MEPNXA MEPNXD MEPNXDX1 MEPNXE MEPR0T MEPR2J MEPTY6 MEPTY7 MEPTY8 MEPTY9 MEPVHM MEPVJ9 MEPVLJ MEPVMR MEPVN7 MEPVN8 MER1ET MER1EV MER1EW MER1EX MER22W MER22WX1 MER22WX2 MER23P MER274 MER27H MER297 MER298 MER299 MER29A MER29AX1 MER29E MER29EX1 MER29H MER29HX1 MER36E MER36H MER3D6 MER3K4 MER3K4X1 MER3LH MER5YR MER601 MER608 MER6H4 MER6H7 MER6HR MER6HT MER6XJ MER6XK MER6XL MER6XY MHEK62 MHEK87 MHEK89 MHEK89X1 MHEKEY MHEKH0 MHEKKL MHEKKT MHEKVW MHEKVWX1 MHEL21 MHEL3T MHEL42 MHEL42X1 MHEL43 MHEL50 MHEL50X1 MHELT7 MHELT8 MHELT8X1 MHELT9 MHELT9X1 MHELTA MHEM77 MHEM78 MHEM81 MHEM8K MHEMP7 MHEMP7X1 MHEMV0 MHEMV0X1 MHEMYT MHEMYTX1 MHEN0J MHEN0JX1 MHEN0K MHEN0KX1 MHEN2R MHEN8D MHEN8DX1 MHEN8J MHEN8JX1 MHEN8K MHEN8M MHEN8MX1 MHENMT MHENR1 MHENX0 MHENX4 MHENX4X1 MHEP15 MHEP2W MHEP82 MHEP82X1 MHEPAX MHEPAXX1 MHEPAY MHEPAYX1 MHEPD0 MHEPKJ MHEW70 MHEW70X1 MHEWD8 MHEWD8X1 MHEWJE MHEX07 MHEX07X1 MHEX08 MHEX29 MHEX29X1 MHL70A MHL70N MHL710 MHL712 MHL72K MHL72L MHL72M MHL72N MHL72P MHLE5K MHLE5L MHLE5M MHLE5N MHLE5P MHLE5R MHLHR3 MHLHR4 MHLHR6 MHLHRK MHLHRL MHLHRR MHLHRX MHLJ4X MHLJ50 MHLJ9M MHLMKE MHM07R MHM07T MHM07V MHM07W MHM07X MHM13V MHM14P MHM14R MHM14T MHM14V MHM158 MHM1AN MHM1VN MHM1VW MHM1VX MHM1VY MHM4N4 MHM4N5 MHM4N7 MHM4N8 MHM4N8X1 MHM4NA MHM771 MHM772 MHM775 MHM778 MHM7V8 MHM87A MHM87D MHM88W MHM88Y MHM8A3 MHM8AL MHM8HY MHM8LK MHM8LL MHM8LP MHM8LR MHME14 MHME21 MHME22 MHME23 MHME24 MHME8T MHRAAR MHRAAT MHRAAV MHRAAW MHRAVY MHRAW0 MHRAW1 MHRAW2 MHRAW3 MHRAW4 MHRAW5 MHRAW6 MHRAW7 MHRDYM MHRDYN MHRDYP MHRDYR MHRE3L MHRE3M MHRE3N MHRE3P MHRKWY MHRKX1 MHRKX2 MHRKX3 MHRKX4 MHRKX6 MHRKX7 MHRKX8 MHRLME MHRLMH MHRLMJ MHRLMK MHRLML MHRLMM MHRLMN MHRLMP MHRLMR MHRMAH MHRMAJ MHRMAK MHRMAP MHT4LH MHT4P5 MHT4PL MHT4PM MHT4PX MHT4RH MHT4TJ MHT4TK MHT4TL MHT514 MHT541 MHT547 MHT574 MHT5AT MHT5DN MHT5HM MHT5MJ MHT5RD MHT5T4 MHT60R MHT60V MHT62T MHT62V MHT63Y MHT640 MHT647 MHT648 MHT9ET MJHP6M MJHP78 MJHP9A MJHP9D MJHP9E MJHP9H MJHPDJ MJHPDL MJHPDM MJHPDN MJHPJX MJHPJY MJHPN3 MJHPP8 MJJ0XP MJJ0XR MJJ0XT MJJ0XV MJJ12D MJJ12E MJJ14V MJJ173 MJJ19D MJJ1E3 MJJ1JM MJJ1L2 MJJ1M5 MJJ1PT MJJ1XX MJJ1XY MJJ1Y2 MJJVEL MJJVEM MJJVEN MJK0TV MJK0VK MJK0VW MJK0W6 MJK11V MJK163 MJK170 MJK1A2 MJK1AL MJK1L6 MJK1N8 MJK1TV MJK1V5 MJK1V6 MJK1V7 MJK1V8 MJK26P MJK26R MJK26T MJK26V MJK2T6 MJK2T7 MJK2T8 MJK2T9 MJK3N4 MJK3N5 MJK3N6 MJK3N7 MJK8M1 MJK8M2 MJK8M3 MJK8M4 MJK8M5 MJK91Y MJK921 MJK922 MJMV10 MJMVD2 MJMVTX MJMWD6 MJMWX6 MJMX0J MJN031 MJN0J0 MJN12A MJN15Y MJN194 MJN19T MJN1D7 MJN1MK MJN1R1 MJN1TM MJN267 MJN2X2 MJN36T MJN3L5 MJN3YX MJN4AA MJN4TY MJN57D MJN5A5 MJN5DT MJN5JR MJN67D MJN6DT MJN6JR MJN6T0 MJN714 MJN7JA MJN7TR MJN842 MJN8TN MJN9ED MJN9XP MJNA68 MJNAD9 MJNAY1 MJND5V MJNDK7 MJNDN3 MJNETN MJNEXK MJNH54 MJNH59 MJNHD0 MJNHY5 MJNJ8V MJNJEX MJNJYM MJNK88 MJNKNN MJNKT8 MJNLAH MJNLRJ MJNM3V MJNM96 MJNMD8 MJNML2 MJNN43 MJNN9N MJNP1V MJNP7P MJNP99 MJNPRR MJNPRX MJNR2R MKA0YP MKA10V MKA1AL MKA1AX MKA1HV MKA1HX MKA1N0 MKA1T8 MKA1X6 MKA289 MKA2L4 MKA2MX MKA30J MKA35A MKA35P MKA3KJ MKA486 MKA4K9 MKA5JT MKA5K5 MKA5LK MKA5V7 MKA623 MKA62W MKA6HN MKA6VL MKA6WP MKA71X MKA7XM MKA834 MKA93X MKA9JN MKAA01 MKAA62 MKAAHV MKAAJJ MKAAR7 MKAD6R MKADEM MKADH9 MKADJ9 MKADK8 MKAE24 MKAHK9 MKAK58 MKAKJX MKAL0J MKAL8L MKAL8Y MKALJ7 MKALWW MKALYW MKAM74 MKAMMH MKAMR7 MKAN3Y MKANP5 MKAPLN MKAPP5 MKAPYV MKARDN MKARMA MKARP3 MKARWK MKATMV MKAV3Y MKAV5E MKAWNY MKAXE1 MKAXTX TWJMJD TWJMJDX1 TWKMJD TWKMJDX1 TWNMNE TWRMNE TWTMNE TXXMNE V28MHE V29MHE V29MHEX1 V2AMHE V2VMDE V8EMJD V8EMJDX1 V8HMJD V8KMJD V8LMJD V8LMJDX1 V8MMJD V8MMJDX1 V8WMJD V91MJD V91MJDX1 V92MJD V92MJDX1 V93MJD V93MJDX1 V93MJDX1X1 VAJMLE VE8MAE VE9MAE VE9MME VEAMAE VEAMME VEDMAE VEDMME VEEMME VK6MJE VKHMLE VKJMLE VKKMLE VKLMLE VM2MJE VM3MJE VM5MJE VMAMKA VMDMKA VMDMKAX1 VMDMKAX1X1 VMDMNE VMEMNE VMRMNE VMTMNE VR7MKA VR9MKA VR9MKAX1 VRMMKA VV2MME VV3MME VV6MKD VV6MKDX1 VVYMKD VW2MKD VWTMKD VWTMKDX1 VX3MME VY2MME VY5MME VYVMKD
• 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.