FDAFDA · Food and drugs·Recall number Z-2292-2018
LFIT Anatomic CoCr Femoral Heads, 6260-9-036
Published July 11, 2018 · Recall initiated: May 22, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Howmedica Osteonics Corp.
- Distributor
- 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.
- Lot
- 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 MH
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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