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-2297-2018
• 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. 6260-9-144
• Code Information: Lots 869MPA 869MPAX1 87PMKD 8A3MKD 8A3MKDX1 8ARMRD 8DTMKD 8EVMRD 8EVMRDX1 8KRMPA 8KRMPAX1 8M2MRD 8RVMRD 8TDMPA 8TDMPAX1 8TTMPD 8V6MPD 8V9MPD 8V9MPDX1 8VVMPD 8X1MPD 900MPD 913MPD 938MPD 938MPDX1 94JMLD 94YMPA 94YMPAX1 94YMPAX2 9LHMLD 9M3MLD 9R2MAD 9R2MADX1 9R4MAD 9R5MAD 9R5MLA 9R6MAD 9R7MAD 9R7MADX1 9RMMLA 9RYMLA 9RYMLAX1 9TEMLA 9V9MRA 9VAMRA 9VDMRA 9VDMRAX1 9VEMRA 9YYMPD 9YYMPDX1 A00MPD A00MPDX1 A08MPD A09MPD A09MPDX1 A2EMEE A2HMEE A2JMEE A2KMEE A4DMLD A53MEE A5AMLA A5DMLA A5HMLA A6XMEE A77MLD A94MEE AA1MLD AA2MTA AA2MTAX1 MHDY1K MHDY28 MHDY28X1 MHDY2D MHE0N7 MHE0TW MHE0W3 MHE0W3X1 MHE0WL MHE10K MHE10X MHE118 MHE11A MHEKK3 MHEKME MHEKVT MHEKVTX1 MHEKW5 MHEKW5X1 MHEL3L MHEL3Y MHEL3YX1 MHEL4D MHEL4R MHEL4RX1 MHEL80 MHEL80X1 MHEL8D MHEL8DX1 MHELD9 MHELD9X1 MHELK6 MHEM74 MHH4EX MHH4EXX1 MHH4LW MHH4W7 MHH514 MHH53R MHH549 MHH54A MHH54D MHH54E MHH55W MHH55WX1 MHH55X MHH5DR MHH5DRX1 MHJ1N0 MHJ235 MHJ237 MHJ26D MHJ26E MHJ28T MHJ2H9 MHJ2KM MHJ2MM MHJKJM MHJKJV MHJKK3 MHJKK5 MHJLAH MHJLEM MHJLJ8 MHJLPN MHJLR4 MHJM1X MHJM37 MHJM4J MHJM4Y MJKNMH MJKPAP MJKPAR MJKPAV MJKPAW MJKPHP MJKPHR MJKPHT MJKPHW MJKPLA MJKPLD MJKPLE MJKPLH MJKR11 MJKR12 MJKVNW MJKVNX MJKVNY MJKVP0 MJKWT7 MJKWT9 MJKWTA MJKWTD MJKX1A MJKX1D MJKX1E MJKX1H MJL33T MJL45Y MJL68K MJL8PJ MJLH0V MJLH65 MJLHDR MJLL6Y MJLN33 MJLP37 MJLP88 MJLV6J MJM0HD MJM93L MJMER8 MJMHXP MJMJT3 MJMK4A MJMLJ8 MJMLRT MJMM18 MJMPWP MJMR45 MJMRJV MJMRTD MJMTD6 MJMVAV MJMX9K MJMYTM MJN2T2 MJN72M MJN93E MJN9K1 MJNAKE MJNEAV MJNEWA MJNJJX MJNJVJ MJNK7K MJNLE9 MJNREV MJP1N2 MJP1NH 009MJE 00AMJE 021MME 0D7MDE 0NXMLA 0P1MLA 0PHMLA 0PNMLA 0PXMLA 0RAMLA 0X9MDE 0X9MDEX1 0XAMDE 0XDMDE 109MMA 109MMAX1 10AMMA 10AMMAX1 10DMMA 10EMMA 10PMMA 116MJD 117MJD 118MJD 119MJD 11AMJD 11DMJD 11EMJD 11HMJD 127MME 128MME 129MME 12TMPE 12XMDE 12YMDE 130MDE 131MDE 13LMLA 13LMLAX1 AA3MTA AA4MTA AA4MTAX1 AA5MTA ALRMLD ALWMLD AT3MKD AT4MKD AT5MKD AT5MKDX1 AVYMKD AW0MKD AW1MKD AX6MKD AXMMKD AXXMKD D2MMKD D2MMMA D2MMMAX1 D2RMMA D30MMA D3AMMD D3DMMD D3DMMDX1 D3EMMD D3HMMD D49MTD D4AMTD D4DMTD D4EMTD D50MLD D6VMKD D80MMA D80MMAX1 D81MMA D8DMMD D8DMMDX1 DDHMMA DDJMMA DDJMMAX1 DDKMMA DE4MMD DHTMLD DJWMMA DJXMMA DJXMMAX1 DJXMMAX1X1 DJYMMA DJYMMAX1 DK0MMA DK1MMA DK1MMAX1 DL3MKD DVYMJE DVYMJEX1 DWXMJE DYJMJE DYJMJEX1 DYKMJE DYLMJE EA7MPA EA8MPA EA9MPA EA9MPAX1 EARMTD EATMTD EAVMTD EAWMTD EDEMME EDKMME MHJM66 MHJMPT MHJN0K MHJN6A MHJN6X MHJN7H MHJN7M MHJNAN MHJNAP MHJNLW MHKNX5 MHKNXJ MHKP0Y MHKP4H MHKP7W MHKP9J MHKPJ7 MHKPJ9 MHKPP5 MHKPP6 MHKPP7 MHKPT1 MHLTLN MHLTLP MHLTLR MHLTLT MHLTLV MHLV7A MHLV7H MHLV7K MHLV8N MHLV96 MHLW7R MHLW89 MHLW8X MHLWAY MHLWD0 MHLWD1 MHLWD2 MHLWD3 MHLWR7 MHLWR8 MHLWR9 MHLWRA MHMWLT MHMWMH MHMWMR MHMWMT MHMWNW MHMWNX MHMWP0 MHMWP1 MHN004 MHN028 MHN02L MHN03J MHN0AR MHN0EW MHN0KY MHN0TN MHN0VH MHN0VJ MHN0VK MHN0XK MHN0XL MHN0XM MHN0Y4 MHN20R MHN22A MHN244 MJP1PK MJP79H MJP7T4 MJP81A MJP8P3 MJP9JK MJPDNH MJPE26 MJPEWM MJPHEE MJPKLW MJPLRV MJPLTY MJPM88 MJPNA7 MJPP14 MJPPH2 MJPPYV MJPR1K MJPR74 MJPV7R MJPVA5 MJPVH5 MJPVR4 MJPVYA MJT184 MJT3PT MJT93V MJT98T MJT9KE MJT9WT MJTDPA MJTDTW MJTE3M MJTH3K MJTKPT MJTKT9 MJTM5J MJTMDK MJTN05 MJTP4V MJTP53 MJTRE0 MJTTXV MJTVA8 MJTWJH MJTX31 MJTY08 MJTY28 MKD094 MKD0N1 MKD3P7 MKD482 MKD4LM MKD6L4 MKD84V MKD9D8 MKD9PP MKDAX4 MKDAXP MKDE32 MKDEAW MKDLY3 MKDN6E MKDNPW MKDP0W MKDPYY MKDW8P MKDW9W MKDX46 164MPE 1JMMPE 1MPMMA 1N4MMA 1NEMPE 1RYMRA 1TDMPE 1X3MRA 1X4MRA 1X5MMA 1X5MMAX1 1X6MMA 1X7MMA 1X7MMAX1 1X8MMA 1X8MMAX1 1X9MMA 1XAMMA 1XAMMAX1 1XDMMA 1Y9MMA 1YAMMA 1YDMMA 1YDMMAX1 1YEMMA 1YEMPE 205MPE 20HMJD 23DMPE 23LMPE 23YMPE 253MPE 254MPE 2MLMND 2MLMNDX1 35KMHD 35MMHD 35NMHD 35RMHD 3KLMAE 3KRMAE 3KXMAE 3L1MAE 4KEMHE 4KHMHE 4M5MKE 4NHMHE 4NJMHE 4NKMHE 4NLMHE 4R3MHD 4R4MHD 4R6MHD 4R8MHD 4RHMHD 4RJMKE 4RRMKE 4RYMJD 4T1MJD 4T3MKE 4T4MJD 4T5MJD 4V8MKE 4YEMRA 4YHMKE 4YHMRA 4YHMRAX1 52TMLE 52VMLE 52WMLE EDTMME EJEMAE EYHMAD EYJMAD EYKMAD EYLMAD EYLMADX1 EYMMAD EYNMAD EYNMADX1 H02MAE H6TMAE H6WMAE H82MAE H83MAE H84MAE H85MAE HV0MHE HV1MHE HV2MHE HV2MRA HV2MRAX1 HV4MHE HV4MRA HV4MRAX1 HV6MRA HV6MRAX1 J0EMPA J0HMPA J0HMPAX1 J94MND J95MND J95MNDX1 J96MND J96MNDX1 J97MND J97MNDX1 K8XMND K92MND K94MND K96MND KLXMEE KWLMHE L16MEE L17MEE L18MEE L53MEE L58MEE L5TMEE L64MEE L8VMEE LAHMHE LAHMHEX1 LAJMHE LV8MHE LV9MHE LV9MHEX1 LVKMRD M37MMA M37MMAX1 M38MMA M38MMAX1 M39MMA M3DMMA M3DMMAX1 M3EMMA M3HMMA M3RMMA M3RMMAX1 M41MMA MHN27J MHN29T MHN2J7 MHN2T1 MHN2T1X1 MHP3AX MHP3AY MHP3D0 MHP3D1 MHP40X MHP40Y MHP410 MHP411 MHP412 MHP414 MHP416 MHP417 MHP7H8 MHP7H9 MHP7HD MHP7HM MHP7KJ MHP7KK MHP7P3 MHP7P4 MHP7P5 MHR3LJ MHR3LM MHR3LN MHR3LP MHR470 MHR472 MHR473 MHR474 MHR4VM MHR4VN MHR4VP MHR4VR MHR6DY MHR6E0 MHR6E1 MHR6E2 MHR6E3 MHR79X MHR79Y MHR7A0 MHR7A1 MHR7A2 MHRN02 MHRN05 MHRN06 MHRN07 MHRNAK MHRNAL MHRNAM MHRNAN MHRNAP MHTM9R MHTMKK MHTMKN MHTMPY MHTMR0 MHTMR1 MHTMY0 MHTMY1 MHTMY2 MHTN2K MHTNAA MHTNDK MHTNDL MKDYTT MKE1XR MKE7E1 MKEELH MKEPN4 MKEPR4 MKEXH9 MV9MRD N4AMTA N4AMTAX1 N4DMTA N4EMTA N4EMTAX1 N4HMTA N9PMDE NE5MDE NE8MDE NE9MDE NLWMDE NMHMDE NR1MPA NR2MPA NTMMDE NTNMDE NTTMDE P68MPD P69MPD PM3MPD PM4MPD PMNMDE PP3MME PP4MME PP5MME PP6MME R1TMKE R1VMKE R1WMKE RE4MME REKMME RELMME REMMME RY4MKE RY5MKE RY6MKE RY7MKE RY9MMA T04MME T05MME T07MME T08MME T0EMDE T0VMMA T0VMMAX1 T0WMMA T0WMMAX1 T0XMMA T0XMMAX1 T10MMA T11MMA T21MKE T22MKE T23MKE T24MKE T26MMA T2DMMA TJMMMD TJNMMD TL1MMD TL4MMD V1NMED 52XMLE 541MKE 58PMLE 59KMLE 5AMMLE 5ANMLE 5APMLE 5ARMLE 5ATMLE 5DWMJD 5DYMJD 5E0MJD 5E2MJD 5HAMJD 63EMNE 63HMNE 63KMNE 63LMNE 69MMKE 6APMKE 6D4MKE 6DYMKE 6EVMKE 6EYMKE 6H6MKE 6H7MKE 6HRMND 6K0MKE 6K1MND 6MNMND 6TXMND 6V6512 6V6514 75KMND 75NMND 78AMND 78EMND 78HMKD 78XMKD 797MJE 799MJE 79DMJE 7A6MKD 7A6MKDX1 7A7MKD 7AEMKD 7D4MRD 7D5MRA 7D5MRAX1 7DDMKD 7DEMKD 7DNMRA 7EAMDD 7EJMJE 7H4MKD 7J7MJE 7JAMKD 7JWMJE 7N7MRD 7NVMJE 7PLMKD 7RLMJE 7T6MRD 80RMKD 865MPA 865MPAX1 866MPA 867MPA 867MPAX1 868MPA M41MMAX1 M48MMA M4HMMA M4HMMAX1 M4NMMA MATMRD MEHMRD MEPHTV MEPHVM MEPJ9X MEPJA9 MEPJDH MEPJHT MEPJT7 MER4D6 MER4JV MER4JVX1 MER4K7 MER4K7X1 MER4KJ MER4KJX1 MER569 MER5K9 MER5MH MER5MV MER5MY MER5TT MER5W2 MER5W9 MER6YN MER705 MER70N MER70P METDD4 METDD6 METDD7 METDD8 MHA1M4 MHA1M5 MHA22X MHA22Y MHA25H MHA25K MHA26W MHA28L MHA4PT MHA4PV MHA4PW MHA4V5 MHA5R2 MHA5RV MHA61R MHAAV9 MHD4YD MHD54K MHD56L MHD57A MHD59D MHD5HW MHD5WR MHD61T MHD61W MHD62N MHD62P MHD64A MHDXMN MHDXXE MHDY09 MHDY0V MHDY18 MHTNJR MHTNJX MHTNPT MHTNPV MHTP95 MHTP99 MHTP9A MHTPA7 MHTPA8 MHTPJ2 MJDAA4 MJDAA5 MJDAA6 MJDAA7 MJDAJD MJDAJE MJDAN1 MJDATE MJDAV1 MJDAW0 MJDAX6 MJDD5N MJDD5R MJDD5T MJDHJH MJDHM6 MJDHRP MJDHXM MJDHYK MJDJME MJDJMH MJDJMJ MJEL4T MJEL64 MJEL8K MJELEL MJELMW MJELMX MJELN0 MJELN1 MJELTV MJELTW MJELTX MJELTY MJEM3D MJEM3H MJHM9H MJHMJE MJHMJV MJHMKT MJHMNA MJHMNE MJHMNH MJHMNJ MJHMXH MJHMXP MJHMXT MJHMXY MJHN2X MJHN50 MJHN52 MJHN53 MJHN54 MJHN55 MJHN73 MJHN74 MJHNDY MJHNEP MJKNMD MJKNME V1RMED V1WMED V22MED V22MEDX1 V25MED V28MED VJ3MLE VJ4MLE VJ5MLE VJ6MLE W4NMED W4PMED W7XMLE XE4MLE
• 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.