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-2293-2018
• 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. 6260-9-040
• Code Information: Lots 586MTA 587MTA 588MTA 588MTAX1 589MTA 5E8MMD 5E9MMD 5EAMMD 5HDMDE 5JKMMD 5JKMMDX1 5L9MPA 5LHMPA 5LJMPA 5LVMPA 5LVMPAX1 5LWMPA 5LXMPA 5MPMTD 5MRMTD 5MRMTDX1 5R0MND 5TDMMD 5V1MND 5V7MHD 5VHMHD 5VTMHD 5W0MHD 5WEMHD 5WKMHD 5WNMHD 5WTMHD 5WVMAE 5WXMAE 5WYMAE 5X0MAE 60RMAE 61DMME 61EMME 61HMME 61HMND 61JMME 61KMDE 61LMDE 61LMDEX1 61MMDE 62HMND 62HMNDX1 62LMMD 63YMAD 63YMADX1 640MAD 641MAD 642MAD 650MDE 65NMMD 662MMD 662MND 665MND 68PMMD 690MED 691MED 692MED 693MED 69DMTD 6A9MTD 6ARMAD 6HNMMD 6HYMAD 6J2MAD EJAMHE EJTMME EJVMME EK2MME EKLMDD EL3MME ENNMRD ETTMPA ETXMPA EVLMDD EXRMRD EXTMRA EXVMRA EXVMRAX1 EY1MRD H0PMHE H0RMDD H0TMTD H0VMTD H0WMTD H0XMTD H0YMTD H16MDD H16MDDX1 H21MHE H36MJE H36MJEX1 H37MJE H38MJE H39MJE H3HMHE H50MRD H51MRD H52MRD H79MHE H90MTD H91MTD H92MTD H9RMTD H9TMTD HH6MHE HHLMMA HHLMMAX1 HHMMMA HHNMMA HHPMMA HHRMMA HHRMMAX1 HJ4MAE HJ5MAE HJ6MAE HJ7MAE HL6MMA HL7MMA HL7MMAX1 HM7MHE HMWMHE HP9MJE HPEMJE HPHMJE HPKMJE HT6MLA HT8MLA HT9MLA HV5MHE HV7MME HV8MME HV9MME HVAMME HVEMRA METHA2 METHAH METHAHX1 METHAJ METHAK METHD3 METHD4 METHDD METMPD METMRL METMRM METMVP METMWM METMXW METMY2 METMY6 METMYE MHA754 MHA755 MHA756 MHA757 MHA8WA MHA8WE MHA8WH MHA8WHX1 MHA8WJ MHAHVH MHAHW2 MHAJ1W MHAJ89 MHAJM0 MHAJM2 MHAJP3 MHAJP4 MHAJP7 MHAJW9 MHAJX9 MHAK18 MHAK18X1 MHAK2L MHAK4L MHAK6R MHANH1 MHANK3 MHANPT MHANX5 MHAP0D MHAP19 MHAP42 MHAP87 MHAPAY MHAPDD MHAPDE MHAPDEX1 MHAPH4 MHDJR8 MHDK8H MHDK8K MHDK8L MHDK8M MHDK8N MHDK8P MHDK8R MHDK8T MHDK8V MHDLAE MHDLAW MHDLDL MHDLDX MHDLEP MHL76M MHL76N MHL76P MHL7NA MHL7ND MHL7NE MHL8AK MHL8E4 MHL8E6 MHL8E7 MHL8EW MHL8EX MHL8HW MHL8LN MHL8V6 MHL8WR MHL8WT MHL8WV MHL8WW MHL97M MHL9KV MHL9V7 MHL9VP MHL9VT MHL9W2 MHL9WD MHL9WE MHL9X3 MHL9X5 MHL9X6 MHLA6Y MHLA70 MHLA72 MHLA73 MHLA74 MHLAWP MHLD04 MHLD06 MHLD13 MHLD14 MHLD15 MHLD23 MHLD24 MHLD2W MHLD3E MHLD3H MHLD3J MHLD3K MHLD3L MHLD3M MHLDTL MHLDXD MHLDXE MHLE23 MHMNM5 MHMNM5X1 MHMNV0 MHMNWL MHMNXD MHMNXE MHMNXP MHMNYA MHMP1D MHMP43 MHMP5W MHMP9D MHMP9DX1 MHMPA6 MHMPD7 MHMPHE MJDAVY MJDAX1 MJDD30 MJDD53 MJDD54 MJDDKJ MJDDKK MJDDKT MJDDKV MJDDKW MJDDKX MJDDMT MJDDMV MJDDMW MJDDMX MJDDPY MJDEAM MJDEJM MJDEKJ MJDENP MJDEWP MJE3M2 MJE3R4 MJE3V7 MJE3VL MJE3XN MJE44N MJE46E MJE4XY MJE4Y1 MJE518 MJE51D MJE548 MJE585 MJE597 MJE5A1 MJE5E4 MJE5HT MJEMAE MJEMKJ MJEMKY MJEML0 MJEML1 MJEML2 MJEP28 MJEP2P MJEP31 MJEP3E MJEP95 MJEP9D MJEP9E MJEPJY MJEPKP MJEPPM MJEPX0 MJHD0M MJHD21 MJHD71 MJHD73 MJHDH2 MJHDH3 MJHDH4 MJHDH5 MJHH92 MJHHYY MJHJ0R MJHJ35 MJHJ8L MJHJHK MJHJJA MJNEM6 MJNETR MJNJL7 MJNK9K MJNL2V MJNL6M MJNLKM MJNLY3 MJNM4X MJNM6P MJNNAW MJNP0R MJNPPM MJNRD5 MJNRNX MJNRP7 MJNV1M MJNVHD MJNVL8 MJNVM9 MJNVV4 MJNWE0 MJNWP7 MJNWPL MJNX41 MJNXTL MJP048 MJP0P1 MJP107 MJP17K MJP27Y MJP29W MJP2YV MJP4J2 MJP4NT MJP54K MJP5ML MJP5T6 MJP650 MJP6P5 MJP6R2 MJP77R MJP820 MJP8K6 MJP9PP MJP9YH MJPD1Y MJPD37 MJPD6D MJPDA7 MJPDDL MJPDNE MJPDWV MJPEHY MJPEN7 MJPHMV MJPHVM MJPJKK MJPJT7 MJPJVT MJPK3J MJPKYH MJPL9W MJPMK7 MJPMLK MJPN6M MJPNA2 MJPNDT MJPNW6 MJPP3K P1AMKD P1DMKD P1DMKDX1 P92MAE P9XMAE PA1MAE PA2MAE PKEMEE PM2MAE PM3MAE PM4MAE PM5MAE PNHMMA PNKMMA PNMMMA PNNMMA PPXMMA R0XMEE R11MEE R12MEE R4PMME R4RMME R4TMME R4WMME R61MPD R6HMPD R9RMPD R9TMPD R9VMPD R9WMPD RV1MPA RV2MPA RV2MPAX1 RV3MPA T0KMDE T0LMDE T0MMDE T0NMDE T3DMEE T50MDE T51MDE T52MDE T53MDE T9PMKA T9PMKAX1 TNJMKA TNMMKA TNMMKAX1 TNNMKA TPPMKA TPPMKAX1 TPVMKA TR9MAE TRDMKA TREMKA TREMKAX1 TYRMJE V0HMAE V20MJE V27MJE V28MJE V2HMAD V2JMAD V2KMAD V2LMAD V2MMAD V2NMAD V2PMAD V2PMADX1 V36MJE 6J6MAD 6K2MKE 6MVMMD 6MVMPD 6N8MPD 6N9MPD 6NAMPD 6NDMPD 6NHMPD 74JMDE 74KMDE 74LMDE 74MMDE 76TMAD 76TMADX1 76WMAD 76XMAD 76YMAD 771MAD 771MADX1 772MAD 77XMKD 77YMKD 780MKD 781MKD 7A5MKD 7A8MKD 7ADMKD 7AHMKD 7D5MTD 7D6MNE 7DVMKD 7HHMNE 7JTMKE 7JWMKE 7KDMKE 7KDMKEX1 7L6MJD 7N6MJD 7N7MJD 7NMMJD 7XTMDE 818MDE 87YMPE 888MPE 898MPE 899MDE 899MPE 89AMDE 8ADMTA 8AEMTA 8AHMTA 8AJMTA 8AJMTAX1 8DJMPE 8DKMPE 8L7MJE 8L8MJE 8L9MJE 8LAMJE 8LVMME 8PHMMA 8PJMMA 8PKMMA 8PKMMAX1 8RVMME 8THMPE 8WEMME 8WKMME 8WLMME HVHMRA HVHMRAX1 HVHMRAX2 HVKMLA HVLMLA J02MHD J0LMHD J1DMLE J1PMHD J1PMHDX1 J1RMHD J1VMHD J1VMHDX1 J1YMHD J1YMHDX1 J20MHD J23MLE J2NMHD J2WMLE J3PMHD J4AMHD J4HMLE J72MLE JE2MTA JE6MHD JH0MHD JMDMRD JMMMRD JMNMRD JPRMRD JR5MRD JRJMHD JTWMJE JW6MHD JXPMHD JYKMHD K28MJE K2JMME K2KMME K2LMME K2MMME K5KMJE K63MJE K6KMJE K6MMJE K7DMJE K7VMJE KLEMKE KPHMKE KPJMKE KRHMME KRMMME KXWMKE L00MED L00MEDX1 L1RMED L1VMED L1WMED L1XMED L1YMED L20MED L22MED L4HMTA L4JMTA L4KMTA L4LMTA L4MMTA L52MPA L53MPA L54MPA MHDLEV MHDM6V MHDM7L MHDMH5 MHDMH6 MHDMJ4 MHDMJ5 MHDMJE MHDMJEX1 MHDVW5 MHDVW6 MHDVW7 MHDVW8 MHDWW2 MHDWY3 MHDWY4 MHDWY5 MHDX25 MHDX3N MHDX7N MHDXKA MHDY16 MHDY24 MHDY25 MHE87P MHE87Y MHE882 MHE884 MHE91J MHE938 MHE93L MHE93N MHE953 MHE98R MHE9E2 MHE9HX MHEHYA MHEHYAX1 MHEJ06 MHEJ06X1 MHEJ0L MHEJ0LX1 MHEJ55 MHEJ55X1 MHEJ56 MHEJ56X1 MHEJ6Y MHEJ70 MHEJ71 MHEJ72 MHEJ72X1 MHEJP4 MHETNM MHETX0 MHETY8 MHEV0R MHEV20 MHEVVJ MHEVWK MHEVWL MHH2Y8 MHH32P MHH32X MHH330 MHH330X1 MHH34R MHH34T MHH34W MHH34WX1 MHH34X MHMPP4 MHMPV3 MHMPWH MHMPWR MHN343 MHN348 MHN349 MHN34D MHN3EM MHN3EN MHN3ER MHN3EV MHN40T MHN40W MHN40Y MHN410 MHN446 MHN44M MHN44N MHN44P MHN44R MHN4AX MHN4AY MHN4D0 MHN4D1 MHN4NL MHN4P7 MHN4P8 MHN4P9 MHNKHX MHNKJV MHNKJX MHNKJY MHNKK1 MHNKRP MHNKRT MHNKT9 MHNKV7 MHNKVR MHNKVT MHNKVV MHNKVW MHNL3V MHNL41 MHNL42 MHNL43 MHNL5L MHNL5M MHNL5N MHNL5R MHNLX3 MHNM04 MHNM05 MHNM26 MHNM27 MHNM2N MHNM2R MHNM42 MHNM43 MHNM44 MHNM45 MHNN20 MHNN28 MHNN2P MHNN2R MHNN65 MHNN66 MHNN7A MHP8R7 MHP8R8 MJHJK3 MJHJK8 MJHK05 MJHK06 MJHR4K MJHR59 MJHR5A MJHR5D MJJ21N MJJ21T MJJ220 MJJ221 MJJ234 MJJ235 MJJ243 MJJ24L MJJ26L MJJ273 MJJ289 MJJ29P MJJ2HM MJJ2M0 MJJ2M1 MJJ2M2 MJJ2M3 MJJ2V5 MJJ2V6 MJJ2V7 MJJ2V8 MJK40D MJK40E MJK40H MJK40J MJK72A MJK762 MJK79T MJK7HJ MJK7M7 MJK7RV MJK7TD MJK8JT MJK8L8 MJK8LX MJK8N2 MJK8RT MJK907 MJK91L MJKEEM MJKEEN MJKEEP MJKEER MJKEKK MJKEKL MJKEKM MJKEMJ MJKENH MJKETL MJKETN MJKETP MJKEVJ MJKH0J MJKH2M MJKH6Y MJKHM8 MJKHM9 MJKHMD MJKHMK MJKHMX MJKHN3 MJKHTY MJPP6D MJPPWA MJPR5D MJPRM4 MJPT88 MJPT90 MJPW9K MJPWWT MJPX30 MJPXLX MJPYD7 MJPYVV MJR0NP MJR0YK MJR1VE MJR322 MJR4VY MJR5VY MJR627 MJR7L7 MJR7NV MJR7Y5 MJR86T MJR86W MJR91D MJR9RM MJR9WL MJRA1V MJRAXE MJRD6X MJRDRV MJRE8N MJRHX8 MJRJ6A MJRJJM MJRJRR MJRJWJ MJRK9N MJRKE6 MJRLLE MJRLLK MJRLR4 MJRNDH MJRNX1 MJRP32 MJRP7Y MJRPL6 MJRPPN MJRR7J MJRRDX MJRT2D MJRTJR MJRW7V MJRX4T MJRXE6 MJRXKJ MJRYWA MKA0MM MKA142 MKA1JT MKA2V6 MKA34A MKA357 MKA3JJ MKA3MM MKA4LM MKA571 MKA5NX MKA5PK MKA69J V40MJE V44MAE V47MAE V5EMJE V5HMJE V5JMJE V5KMJE V9KMMD V9KMMDX1 V9YMJE VAKMJE VARMLE VATMLE VAVMLE VAWMLE VE5MMD VH3MJE VL0MMD VL8MMD VL8MMDX1 VNKMNE VNLMNE VNMMNE VNNMNE VWDMNE VWRMEE VWXMNE VY1MNE VYDMMD VYDMMDX1 VYHMMD W6MMEE WA6MAD WJ8MEE WKTMEE WV1MEE WV1MEEX1 WV2MEE WV3MEE WV4MEE WV5MEE XDJMDE XDKMDE XDLMDE XDMMDE XH9MHE XHAMHE XHDMHE XKMMHE YHNMHE YHTMHE YHVMHE YHVMHEX1 YNJMJE YNKMJE YNLMJE YNMMJE 000MNE 001MNE 002MNE 003MNE 03TMEE 040MEE 043MEE 075MPE 077MPE 079MPE 0DJMNE 0DKMNE 0DLMNE 0DMMNE 0EKMJE 0LEMJE 0RHMPE 0RJMPE 0RKMPE 10AMJD 11EMJE 11HMJE 11MMJD 11NMJD 11PMJD 11RMJD 11TMJD 12XMJD 12YMJD 13YMED 141MED 143MED 144MED 145MED 15PMKE 190MKE 1A1MKE 1A8MKE 1AHMKE 1AYMKE 1D5MKE 1DJMKE 1EXMKE 1HAMKE 1HLMJE 1KPMJE 21PMPA 23EMRD 23HMRD 23JMRD 23KMRD 23LMRD 23MMRD 248MJE 24DMJE 251MLE 8WRMRA 8WRMRAX1 8WTMRA 8WTMRAX1 90DMME 90KMEE 910MME 911MEE 913MME 91PMME 92MMEE 951MPA 952MPA 97RMMA 97RMMAX1 97TMMA 97VMMA 996MEE 9DEMNE 9KNMEE 9L3MNE 9MHMNE 9N5MEE 9R5MNE 9R7MNE 9RAMNE 9RRMNE 9VTMEE 9WEMEE 9WEMPA 9WHMPA 9WHMPAX1 9WJMPA 9WJMPAX1 9XTMMA 9XTMMAX1 A1TMTA A1TMTAX1 A1VMTA A1WMTA A1WMTAX1 A4AMTA A4AMTAX1 A84MMA A9VMDD A9VMDDX1 A9WMDD A9WMDDX1 A9XMDD A9YMDD AA0MDD ADVMMA ADVMMAX1 ADVMMAX1X1 ADWMMA ADXMMA ADYMMA AE0MMA AE1MMA AE2MMA AKEMMA AKEMMAX1 AKHMMA ALYMMA ANMMMA AT8MMD AT8MMDX1 ATTMJD AV0MJD AW5MMD L5HMKE L80MKE L9RMED L9RMEDX1 LD9MKE LDEMRA LDHMRA LDJMRA LDPMRA LDRMRA LDTMKE LEDMKE LEEMKE LH4MKE LHKMKE LHLMHD LJ5MKE LJ9MKE LK3MKE LM0MPD LM1MPD LM2MKE LM2MPD LM3MKE LM4MKE LT6MDD LT8MDD LT8MDDX1 LTNMPA LTPMPA LTTMPA LVMMDD LVWMDD M1TMNA M1VMNA M1VMNAX1 M2TMPA M2YMPA M34MNA M34MNAX1 M35MNA M35MNAX1 M49MPD M4AMPD M4AMPDX1 M4DMPD M7NMKE M7PMKE M8AMKE MEPE22 MEPE23 MEPE25 MEPE26 MEPENN MEPEX8 MEPH52 MEPH53 MEPH6N MEPKK8 MEPKK8X1 MEPKK9 MEPKKA MEPKKD MEPLNX MEPLP2 MEPM1M MEPM2W MEPM54 MEPN9K MEPNEN MHH34Y MHH40J MHH47M MHH47N MHH4LM MHH4LN MHH4PN MHH4PP MHH54K MHH551 MHH55K MHH55L MHH55M MHH55MX1 MHH560 MHHDJY MHHDTY MHHDV4 MHHE4Y MHHE54 MHHEA8 MHHEA9 MHHEE2 MHHEE4 MHHEMX MHHEN9 MHHEPA MHHET0 MHHET1 MHHET2 MHHET3 MHHET4 MHHET5 MHHET6 MHHET7 MHHET8 MHHHK0 MHHHK1 MHJ291 MHJ2KN MHJ2R6 MHJ313 MHJ34H MHJ36L MHJ37P MHJ38T MHJ38X MHJ397 MHJ39K MHJ3HY MHJ3J1 MHJ3J2 MHJ412 MHJ416 MHJ419 MHJ4MA MHJ4MD MHJ4ME MHJ4MH MHJ4MJ MHK839 MHK86Y MHK8HJ MHK8LN MHK8NM MHK8NN MHK8Y0 MHK91A MHK937 MHK93H MHP8R9 MHP8RA MHP90W MHP90X MHP911 MHP912 MHP9RV MHP9RY MHP9T0 MHPA19 MHPA1H MHPA1L MHPA1M MHPA1N MHPLJW MHPLJX MHPLJY MHPLK0 MHPLK2 MHPLK3 MHPLK4 MHPLK5 MHPX1P MHPX1R MHPX1T MHPX1V MHPX1W MHPXMW MHPXNP MHR01N MHR01R MHR01T MHR01V MHR01W MHR06P MHR06Y MHR073 MHR0NW MHR194 MHR195 MHR196 MHR198 MHR1J6 MHR1J9 MHR1JA MHR1JE MHR210 MHR211 MHR266 MHR267 MHR268 MHR26D MHRHL4 MHRHL7 MHRHLD MHRHLH MHRJE2 MHRJE3 MHRJE4 MHRJE5 MHRJE6 MHRJE7 MHRJE8 MHRJE9 MHRMX9 MHRMXD MHRMXE MHRMXJ MHT668 MHT6EV MJKHV0 MJKHV1 MJKHV2 MJKJ2W MJKJ7P MJKKX1 MJKKX3 MJKKX4 MJKKX5 MJKL0D MJKL0E MJKL28 MJKL43 MJKLA7 MJKLDN MJKLHK MJKLJ5 MJL0Y9 MJL11M MJL1EA MJL2L0 MJL33A MJL3RE MJL45W MJL4LR MJL8T6 MJL94K MJL983 MJL9D2 MJL9H7 MJLA1A MJLAVT MJLE4N MJLE7N MJLE8W MJLE8X MJLE8Y MJLE90 MJLED2 MJLED3 MJLED4 MJLEKK MJLEKN MJLEKV MJLEKX MJLELW MJLEM4 MJLEN2 MJLH24 MJLH60 MJLHT5 MJLJ1K MJLJDL MJLLE0 MJLLWD MJLMED MJLMER MJLMM0 MJLMRD MJLN2H MJLNM9 MJLNYD MJLPHL MJLRA7 MJLRJA MJLTKR MJLVV2 MJLW8Y MJLWV6 MJLXKH MKA6KL MKA7VT MKA81K MKA91N MKA969 MKA9ET MKA9TL MKAA9P MKAARX MKAAXT MKADDP MKADMM MKADMT MKAE3M MKAE5V MKAE7X MKAEM3 MKAHX1 MKAJ7D MKAJHY MKAJY3 MKAJYE MKAJYJ MKAK7A MKAKV8 MKAKVD MKAKYD MKAL3L MKAL8J MKALMT MKALRR MKALVE MKAN94 MKANPX MKAP07 MKAP51 MKAP6W MKAP75 MKAPMN MKAPN7 MKAPRE MKARVT MKATM4 MKAV09 MKAV62 MKAVJP MKAVV1 MKAWJT MKAXD4 MKAXRK MKAYEA MKAYPY MKAYY0 MKD18E MKD1J0 MKDAPT MKDD2E MKDD9D MKDDMH MKDHEA MKDHNX MKDMPM MKDMY4 MKDT6E MKDXJW MKE075 MKE08M MKE0AE MKE17E MKE34V 253MLE 254MLE 255MDE 255MLE 25DMDE 25HMDE 25JMDE 29DMHE 29WMHE 2AXMHE 2DMMHE 2E7MHE 2JHMKD 2JHMKDX1 2JJMKD 2JKMKD 2JLMKD 2JLMKDX1 2JMMKD 2JNMKD 2JRMHE 2LTMLE 2LVMLE 2LVMLEX1 2NXMLE 2VEMLE 2Y3MLE 2Y6MLE 2Y7MLE 35LMRD 35MMRA 35NMRA 3RKMAE 3RLMAE 3RMMAE 3RNMAE 3WKMAE 41AMME 455MED 455MEDX1 456MED 457MED 458MED 459MED 45AMED 45JMTD 45XMTD 461MTD 47KMHE 4E8MHE 4EDMHE 4EEMHE 4K0MTD 4K7MTD 4KAMTD 4R5MME 4R6MME 4R7MME 4XYMPA 4Y0MPA 4Y0MPAX1 4Y2MPA 4YXMTD 53LMEE 53MMEE 53NMEE 53PMEE 53YMTD 540MTD 585MTA AW8MND AWHMND AWHMNDX1 AXAMJD AXHMND AXHMNDX1 AXNMKD AXNMKDX1 AXTMMA AYNMKD D0YMMD D11MMD D19MMD D1EMND D1LMJD D1LMJDX1 D2AMKD D2AMKDX1 D30MKD D4TMND D74MEE D75MEE D76MEE D77MEE D7PMJD D7PMJDX1 D8WMND D9NMND D9YMLE DA0MLE DA1MLE DA2MLE DD2MEE DDMMMA DDNMMA DDPMMA DE1MND DEEMEE DHJMKD DLWMND DM3MEE DNYMKD DPMMEE DT8MKD E13MLE E16MLE E22MLE E2DMLE E36MPA E38MNE E3KMND E3LMND E3MMND E3YMNE E49MPA E49MPAX1 E4XMNE E5AMPD E5VMND E5WMND E5XMND E67MPD E68MPD E6JMPD E6WMNE E6YMPD EADMHE EAMMDD EEDMDD EEEMME MEPNER MEPNET MEPNETX1 MEPNETX2 MEPNXN MEPTA6 MEPTD7 MEPTHN MEPTMR MEPTN5 MEPTN6 MEPTYW MER3DA MER3DN MER3M0 MER3M1 MER3WE MER3WEX1 MER3WH MER41V MER48R MER4DY MER4E0 MER4E2 MER4K1 MER4K3 MER85M MER85MX1 MER88M MER88T MER88TX1 MER893 MERH5P MERH5PX1 MERH6L MERH6M MERH6N MERHPP MERHPR MERHRD MERJVV MERJVVX1 MERK3A MERK6W MERK6Y MERL38 MERL39 MET7MP MET7MPX1 MET7MR MET7MRX1 MET7MT MET7MV MET7MVX1 MET80N MET80P MET80R MET80RX1 MET80T METD4V METD4W METDD0 METDD1 METDD1X1 METEHM METEHR METEHT METEHTX1 METEHV METHA1 MHK93K MHK946 MHK947 MHK996 MHK9DE MHK9JT MHK9LH MHK9LJ MHK9LK MHK9YN MHKA07 MHKA08 MHKA10 MHKA1D MHKA28 MHKA2V MHKA31 MHKA44 MHKA46 MHKA47 MHKA97 MHKA98 MHKAAN MHKAAP MHKAPD MHKAPE MHKAPH MHKAPJ MHKD35 MHKD76 MHKD8N MHKD8P MHKD8X MHKD90 MHKD90X1 MHKD96 MHKDA1 MHKDJM MHKDM1 MHKDM2 MHKDM3 MHKDWA MHKDWD MHKE38 MHKE69 MHKE7L MHKE85 MHKE86 MHKE89 MHKE8D MHKE90 MHKE92 MHKEDL MHKEVX MHKH2A MHKH71 MHKH7J MHKH7L MHKH7N MHKH84 MHKH85 MHKH8R MHKH8T MHKH9D MHKHRR MHKHT4 MHKHTE MHKHXD MHL76K MHL76L MHT6KE MHT6PE MHT6TM MHT6WE MHT74X MHT74Y MHT76Y MHT774 MHT775 MHT78M MHT78N MHTAPH MHTAR1 MHTAYR MHTD14 MHTD3Y MHTD7Y MHTD9L MHTD9X MHTDD5 MHTDDD MHTDL6 MHTDL9 MHTDME MHTDMH MHTDMW MJA2TP MJA2TR MJA2TV MJA2TW MJA2TY MJA2V0 MJA2V1 MJA2V2 MJA2V3 MJA3T6 MJA3T7 MJA3T8 MJA3T9 MJA45N MJA45P MJA45R MJA45T MJA4J7 MJA4J9 MJA4JA MJA4JD MJA502 MJA503 MJA504 MJA505 MJD00L MJD010 MJD05P MJD08D MJD0HY MJD0KA MJD0P7 MJD10J MJD10K MJD133 MJD135 MJD162 MJD17L MJD17M MJD17N MJD17Y MJD18D MJD192 MJDAV6 MJLY34 MJLYVA MJM0YW MJM1KD MJM1KM MJM1MV MJM1NH MJM1W5 MJM1WY MJM292 MJM2WW MJM380 MJM504 MJM5R7 MJM5YJ MJM624 MJM637 MJM63H MJM7A7 MJM7J6 MJM8W9 MJM93R MJM9L8 MJMAP6 MJMENH MJMEP5 MJMJ11 MJMK65 MJMN3K MJMNTD MJMP2X MJMP48 MJMP7D MJMPN7 MJMPPJ MJMR4J MJMRTP MJMT95 MJMV43 MJMVRT MJMW8A MJMWH6 MJMXW5 MJN174 MJN224 MJN28Y MJN60P MJN68D MJN6D0 MJN6T8 MJN75Y MJN7MH MJN8MV MJN93A MJN978 MJN9D8 MJN9HD MJN9P6 MJN9TP MJN9V3 MJN9W6 MJNA43 MJNA7V MJNATL MJNAV9 MJND42 MJND9P MJNDKK MJNEE0 MJNEJH MKE40W MKE41Y MKE469 MKE6YT MKE7LV MKE8LA MKE970 MKEA7M MKEJ33 MKEKNA MKEMPX MKEND4 MLDMEE MN9MEE MP0MKD MPEMEE MPHMEE MPJMEE MPKMEE MPLMEE MPMMEE MVHMLE MW0MLE MW1MLE MW2MLE MW3MLE MX1MKD MX7MED MX8MKD MXRMED MY2MED MYRMKD MYTMKD N0NMKD N0XMKD N10MKD N1MMHE N1PMHE N1RMHE N1VMHE N4LMKD N4LMKDX1 N4RMPA N4RMPAX1 N4YMPA N52MPA N55MPA N55MPAX1 N9AMMA NEHMMA NKKMMA NKLMMA NKNMMA NKVMMA NR0MKD NW8MMA NW8MMAX1 NXHMKD NXJMKD NYPMKD NYRMKD P02MKD P03MKD P03MKDX1 P0HMLE P0MMKD P0NMKD P0TMLE P0VMLE P0WMLE
• 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.