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-2294-2018
• 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. 6260-9-044
• Code Information: Lots 3P9MKE 3PEMKE 3PHMKE 3PJMKE 3PKMKE 3XJMKE 3XKMKE 44EMJD 44HMJD 44JMJD 46NMRA 46PMRA 46PMRAX1 46RMRA 485MJD 487MJD 488MJD 48AMJD 48EMJD 4A5MJD 4A5MJDX1 4DYMHE 4E2MHE 4E3MHE 4E4MHE 4KPMTD 4Y2MTD 4Y3MTD 4Y4MTD 54KMJD 54LMJD 54MMJD 67VMLE 6D7MLE 6DPMLE 6DXMLE 6K3MKE 6LHMKE 6LLMKE 6LMMKE 6LNMKE 6NMMKE 6R1MKE 7AJMRA 7AJMRAX1 7AKMRA 7AKMRAX1 803MMD 805MMD 806MMD 807MMD 807MMDX1 80AMMD 80DMMD 85MMPA 85NMPA 85PMPA 8J0MPA 8Y6MRD 918MRD 91RMRD 92XMND 939MND 93HMND 94VMPA 94XMPA 94XMPAX1 9JMMRD 9KKMRD 9T3MPD MHH6ML MHH6VE MHH728 MHJ39H MHJ3JR MHJ3K9 MHJ3NE MHK4AJ MHK4RV MHK53A MHK53E MHK54J MHK54K MHK5AD MHK5DJ MHKL67 MHKL7R MHKLP2 MHKLP4 MHKLTD MHKLTE MHKLVL MHKLWD MHKLXJ MHKM15 MHKME5 MHKMT6 MHKMY0 MHKN2A MHKN4T MHKN70 MHKND1 MHKNR0 MHKNR6 MHKNRX MHKNTY MHKNV0 MHKNV1 MHLPVJ MHLR02 MHLR0D MHLR0J MHLR0L MHLR4J MHLR60 MHLR61 MHLR62 MHLRK5 MHLRTL MHLRTP MHLRTT MHLRTW MHLT13 MHLT3J MHLT3L MHLT4P MHLT51 MHLT82 MHLT83 MHLT84 MHLT85 MHN2YM MHN316 MHN35M MHN3EH MHP421 MHP422 MHP424 MHP425 MHP426 P65MPD P66MPD PA1MDE PAWMDE PNVMLA PNYMLA PP0MLA PP1MLA PP2MLA PVTMMA PVVMMA PVWMMA R3KMMA R3RMMA R3RMMAX1 R3XMMA R3XMMAX1 R4TMMA R4TMMAX1 R4VMMA RHEMLA RHJMLA RHKMLA RHKMLAX1 RHKMLAX1X1 RHLMLA RHLMLAX1 RHMMLA RHNMLA RHNMLAX1 RHPMLA RNYMME RP3MMA RPWMME RPXMME RPYMME RTRMMA RV4MMA RV4MMAX1 RV5MMA RV6MMA RV7MMA VJ7MLE VJ8MLE W8PMLE X5AMLE X8LMLE 0H4MLA 0H4MLAX1 0KKMMA 0KKMMAX1 0KKMMAX1X1 0KLMMA 0KMMMA 0KPMMA 0KRMMA 0KRMMAX1 0KVMJE 0L9MJE 0M5MLA 0TWMMA 0TXMMA 0TYMMA 0V0MMA 0V1MMA 0V1MMAX1 0WXMRA 0WYMRA 0X0MRA 0X2MRA 14EMDE 14HMDE 14JMDE 14KMDE 155MJE 157MJE 158MJE 1JLMJE 262MHD 263MHD 265MHD 266MHD 267MHD 268MHD 269MHD 2NDMKE 2NEMKE 2NHMKE 2NJMKE 325MAE 336MAE 35HMHD 35HMHDX1 35JMHD 376MAE 379MKE 3E4MAE 3HMMKE 3JRMNE 3JTMNE 3JVMNE 3JWMNE 3L1MKE 3M5MKE 3N1MKE 3N2MKE 3NMMJD 3NPMJD 3NTMJD 3NYMJD 3P0MJD 3P1MJD 3P2MJD 3P2MKE 3P3MJD 3P5MJD 3P7MJD MER6XA MER6XAX1 MER6YE MHA3K9 MHA3L5 MHA3L7 MHA3LA MHA3RP MHA3RR MHA3RT MHA3RV MHA3RW MHA4KX MHA4KY MHA4M2 MHA4M3 MHA4PJ MHA4PK MHA4PL MHA4PM MHA4PN MHA5V1 MHA5YR MHD3L3 MHD3PM MHD3V6 MHD3V6X1 MHD414 MHD416 MHD419 MHD4E4 MHD4LW MHD4LWX1 MHD4MA MHD4ME MHD4XD MHD4XE MHD4Y0 MHE125 MHE13E MHE15M MHE18T MHE1DK MHE1HY MHE1JR MHE1XV MHE1Y6 MHE1Y7 MHE21P MHE21X MHE21XX1 MHELRT MHELV5 MHELYN MHEM6H MHEM6HX1 MHEM7D MHEM82 MHEM82X1 MHEM83 MHEM83X1 MHEM8A MHEM8AX1 MHEM9K MHH666 MHH667 MHH69L MHH6D5 MHH6J7 MHH6LE MJP78E MJPDT2 MJPDYM MJPE99 MJPKV6 MJPMNE MJPMVN MJPNT6 MJPNTM MJPTW2 MJPWN1 MJT1WN MJT21H MJT276 MJT2WD MJT3K3 MJT430 MJT49D MJT6NN MJT6R1 MJT713 MJT8PJ MJTARJ MJTAXR MJTEAN MJTEE8 MJTHY1 MJTL78 MJTNVK MJTP40 MJTPDE MJTPHV MJTRHE MJTRWD MJTT9E MJTTER MJTVP6 MJTW3K MJTW4D MJTW71 MKDA09 MKDAAX MKDMWX MKDPAM MKDTAK MKDTKX N4NMTA N4PMTA N4RMTA N64MME NA5MME NAEMME NEPMME NJYMTA NPYMPA NPYMPAX1 NR0MPA NR3MPA NR4MPA NX4MDE P2EMPD P33MPD P46MMA P46MMAX1 P47MDE P47MMA P4XMPD P4YMPD P57MPD P58MPD 022MME 024MME 025MME 026MME 059MLA 059MLAX1 07DMMA 0ELMLA 0ELMLAX1 0EVMJE 0EVMLA 0EXMJE 0EYMLA DYDMKD DYDMKDX1 DYJMME DYKMME DYLMME DYMMME E0JMKD E4DMPA E4EMPA E5HMLD E5JMLD E7MMJE E7TMJE E7VMJE E7WMJE E9KMLD E9KMLDX1 E9NMLD HDDMND HDHMND HDJMND HDLMND HM6MHE HN3MHE HN4MHE HN5MHE HTWMRA HTXMRA HTXMRAX1 HTYMRA J4RMND J51MND J54MND J55MND J56MND K27MAD K27MADX1 K29MAD K29MADX1 K2DMAD K2HMAD K2KMAD K2KMADX1 L53MAE L54MAE L55MAE L56MAE L9MMEE LKKMEE LKLMEE LMTMEE MEPETX MEPH6L MEPH74 MEPH7H MEPH7J MEPH7R MEPH7RX1 MEPJPA MEPJYY MEPK19 MEPK51 MEPK52 MEPK7X MER5XH MER63Y MER69K MER6AE MER6WH MER6WY MJJHPX MJJHPY MJJHR0 MJJJ7L MJJJ7P MJJJ7W MJJJ7Y MJJJA7 MJJJD6 MJJJD7 MJJJD8 MJJJDA MJKK0H MJKK0J MJKK0K MJKK0L MJKKA6 MJKL12 MJKL13 MJKL4J MJKL4K MJKL9K MJKL9L MJKL9M MJKL9N MJKM2A MJKM2D MJKM2E MJL0DT MJL0LX MJL251 MJL3RT MJL7YW MJLEAE MJLEH8 MJLHY2 MJLM12 MJLRJD MJLYK6 MJLYL4 MJM213 MJM2JY MJM303 MJM58J MJM6YD MJM797 MJM7NN MJM8E7 MJM8EA MJM8JW MJM8KY MJM8LA MJM8X0 MJMAKW MJMANL MJMAX5 MJMD4W MJMDDA MJMDK0 MJMDX7 MJMENX MJMJNY MJMLD4 MJMLDV MJMM6V MJMN9D MJMNNR MJMX4L MJMX8M MJP04M 9T3MPDX1 9T5MPD 9W5MPD 9W7MPD 9W7MPDX1 A3XMMA A3YMMA A3YMMAX1 A40MMA A41MMA A43MMA A4DMTA A4DMTAX1 A4EMTA A4HMTA A4JMTA AEXMEE AJAMMA AJDMMA AJDMMAX1 AJEMMA AJHMMA AJHMMAX1 AJJMMA AJJMMAX1 AJKMMA AJKMMAX1 AJLMMA AJMMMA AJMMMAX1 ALHMEE AM7MRA AMKMMA AMKMMAX1 AMKMRA AMLMRA AMLMRAX1 AMMMMA AMMMMAX1 AMNMMA ANHMLA ANHMLAX1 AP8MLA APLMLA ARTMEE ARVMAD ARVMADX1 ARXMAD ARYMAD AT0MAD AWTMLA AWTMLAX1 AWWMLA AWYMLA D0EMLE D23MEE D2LMLE D2MMLE D32MLE D78MEE D79MEE D7AMEE D7DMEE D99MTA DVTMKD DVVMKD DVVMKDX1 DVWMKD DY9MKD DYAMKD MHP69W MHP69X MHP69Y MHP6RA MHP6RD MHP6RE MHP6RH MHP6RJ MHP6RK MHP6RM MHP6RN MHR572 MHR573 MHR574 MHR575 MHR576 MHR8MN MHR8MP MHR8MR MHR8MT MHRPAN MHRPHP MHRPHR MHRPHV MHRPHW MHRPL6 MHRPL8 MHRPLA MHRPLD MHRR3W MHRR8M MHRR8P MHRR97 MHRR98 MHRRA5 MJA3W5 MJA426 MJA43P MJA457 MJA49J MJA4EP MJA4NY MJA4R1 MJA4WK MJA4Y1 MJA4YM MJA4YV MJA506 MJA51N MJA51P MJA55K MJA5DR MJA6D8 MJA6D9 MJA6DA MJA6DD MJA6PA MJA6TT MJA6YD MJA72X MJA744 MJA77Y MJA7A2 MJA80D MJEMAD MJEMMW MJEMVL MJEMVX MJJHHL MJJHPW
• 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.