Class 2 Device Recall Alteon XLE

• Date Initiated by Firm: December 31, 2024
• Date Posted: February 12, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1167-2025
• Recall Event ID: 96102
• 510(K)Number: K182502
• Product Classification: Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
• Product: Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM 140-28-51 NV EHXLNTRL LNR G1 28MM 140-28-52 NV EHXL NTRL LNR G228MM 140-32-51 NV EHXL NTRL LNR G132MM 140-32-52 NV EHXL NTRL LNR G232MM 140-32-53 NV EHXL NTRL LNR G332MM 140-32-54 NV EHXLNTRL LNR G4 32MM 140-32-55 NV EHXLNTRL LNR G5 32MM 140-36-52 NV EHXLNTRL LNR G2 36MM 140-36-53 NV EHXL NTRL LNR G336MM 140-36-54 NV EHXLNTRL LNR G4 36MM 140-36-55 NV EHXLNTRL LNR G5 36MM 140-40-53 NV EHXLNTRL LNR G3 40MM 140-40-54 NV EHXLNTRL LNR G4 40MM 140-40-55 NV EHXLNTRL LNR G5 40MM 142-22-68 NV EHXL ALPLNR G00 22MM 142-22-70 NV EHXL LIPLNR G00 22MM 142-28-50 NV EHXL LIP LNR G0 28MM 142-28-51 NV EHXL LIP LNR G1 28MM 142-28-52 NV EHXL LIP LNR G2 28MM 142-28-60 NV EHXL ALIPLNR G0 28MM 142-28-61 NV EHXL ALIP LNR G1 28MM 142-28-62 NV EHXL ALIP LNR G2 28MM 142-32-51 NV EHXL LIP LNR G1 32MM 142-32-52 NV EHXL LIP LNR G2 32MM 142-32-53 NV EHXL LIP LNR G3 32MM 142-32-54 NV EHXL LIP LNR G4 32MM 142-32-55 NV EHXL LIP LNR G5 32MM 142-32-61 NV EHXL ALIP LNR G1 32MM 142-32-62 NV EHXL ALIP LNR G2 32MM 142-32-63 NV EHXL ALIP LNR G3 32MM 142-32-64 NV EHXL ALIP LNR G4 32MM 142-32-65 NV EHXL ALIP LNR G5 32MM 142-36-52 NV EHXL LIP LNR G2 36MM 142-36-53 NV EHXL LIP LNR G3 36MM 142-36-54 NV EHXL LIP LNR G4 36MM 142-36-55 NV EHXL LIP LNR G5 36MM 142-36-62 NV EHXL ALIP LNR G2 36MM 142-36-63 NV EHXL ALIP LNR G3 36MM 142-36-64 NV EHXL ALIP LNR G4 36MM 142-36-65 NV EHXL ALIP LNR G5 36MM 142-40-53 NV EHXL LIP LNR G3 40MM 142-40-54 NV EHXL LIP LNR G4 40MM 142-40-55 NV EHXL LIP LNR G5 40MM 142-40-63 NV EHXL ALIP LNR G3 40MM 142-40-64 NV EHXL ALIP LNR G4 40MM 142-40-65 NV EHXL ALIP LNR G5 40MM 146-22-70 NV EHXL LATLNR G00 22MM 146-28-51 NV EHXL LAT LNR G1 28MM 146-32-51 NV EHXL LAT LNR G1 32MM 146-32-52 NV EHXL LAT LNR G2 32MM 146-32-53 NV EHXL LAT LNR G3 32MM 146-32-54 NV EHXL LAT LNR G4 32MM 146-32-55 NV EHXL LAT LNR G5 32MM 146-36-52 NV EHXL LAT LNR G2 36MM 146-36-53 NV EHXL LAT LNR G3 36MM 146-36-54 NV EHXL LAT LNR G4 36MM 146-36-55 NV EHXL LAT LNR G5 36MM 146-40-53 NV EHXL LAT LNR G3 40MM 146-40-54 NV EHXL LAT LNR G4 40MM 146-40-55 NV EHXL LAT LNR G5 40MM 148-32-51 NV EHXL 10 LNR G1 32MM 148-36-52 NV EHXL 10 LNR G2 36MM 148-36-53 NV EHXL 10 LNR G3 36MM 148-36-54 NV EHXL 10 LNR G4 36MM 148-36-55 NV EHXL 10 LNR G5 36MM 148-40-53 NV EHXL 10 LNR G3 40MM 148-40-54 NV EHXL 10 LNR G4 40MM 148-40-55 NV EHXL 10 LNR G5 40MM All Exactech Hip Systems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and for treatment of proximal femoral fractures where prosthetic replacement is determined by the surgeon as the preferred treatment.
• Code Information: Item Number / Product Description/ UDI-DI code: 01-030-40-0022 ALT XLE LNRNTRL G0 22 10885862549433 Serial Numbers: 6771453 6771460 6771467 6771484 6771458 6771456 6771468 6771479 6771444 6771461 6771470 6771474 6771481 01-030-40-0122 ALT XLE LNRNTRL G1 22 10885862549440 01-030-40-0128 ALT XLE LNR NTRL G1 28 10885862549457 Serial Numbers: 6515426 6515434 6750140 6750151 6597399 6597410 6750127 6750132 6750145 6906249 6515440 6597407 6597409 6515443 6597398 6597408 6515428 6750152 6597400 6515441 6515442 6597403 6750164 6906241 6906245 6906258 01-030-40-0222 ALT XLE LNRNTRL G2 22 10885862549464 01-030-40-0228 ALT XLE LNR NTRL G2 28 10885862549471 Serial Numbers: 6532932 6532935 01-030-40-0232 ALT XLE LNR NTRL G2 32 10885862549488 Serial Numbers: 6904616 6436003 6486043 6512970 6512972 6592041 6592052 6838572 6838573 6838629 6904466 6904461 6602279 6602314 6602327 6712220 6826324 6477677 6477682 6602303 6712155 6712221 6838656 6904499 6904606 6486040 6486053 7010390 6838577 6838636 6838651 6904486 6477683 6477717 6904493 6712152 6826293 6838618 7010361 6904495 6592040 6602310 6712167 6592060 6602294 6838648 6712153 6712209 6602316 6712171 6838622 6436004 6477694 6512971 6602304 6826290 6826296 6826303 6838640 6486034 6486044 6592044 6592045 6592064 6592073 6602289 6712193 6826338 6838630 6904473 6904617 6904641 01-030-40-0322 ALT XLE LNR NTRL G3 22 10885862549495 01-030-40-0328 ALT XLE LNR NTRL G3 28 10885862549501 Serial Numbers: 6532515 6532527 01-030-40-0332 ALT XLE LNR NTRL G3 32 10885862549518 Serial Numbers: 6513473 6432053 6513487 6589221 6903725 6925838 6925842 6612985 6669834 6745989 6498816 6678655 6678691 6746005 6925882 6903708 6903745 6903787 6834322 7009964 7009989 6668617 6775084 6826133 6925826 6925808 6482639 6668602 6925829 6925869 6826117 6513478 6369929 6369932 6513522 6513524 6903800 6482645 6903749 6903785 6826099 6826132 6834318 6903757 6904732 6904742 6482636 6497846 6513498 6513516 6612955 6826116 6826124 6826129 6904706 6925807 01-030-40-0422 ALT XLE LNR NTRL G4 22 10885862549532 01-030-40-0428 ALT XLE LNR NTRL G4 28 10885862549549 01-030-40-0432 ALT XLE LNR NTRL G4 32 10885862549556 Serial Numbers: 6519078 6519107 6631759 6725946 6725905 6725925 6725933 6725983 6819098 6844866 6819097 6732247 6725918 6725984 6819119 6924478 6725907 6725923 6732264 6819143 6844882 6481100 6732222 6819134 6270754 6481105 6519096 6568342 6725912 6725974 6732249 6924246 6924490 01-030-40-0436 ALT XLE LNR NTRL G4 36 10885862549563 Serial NUmbers: 6504144 6504149 6510663 6510669 6554146 7030120 6797992 7030044 6798003 6673907 6791157 7030084 6905525 6905610 6905742 6798005 6798018 7030114 6797997 6366475 6510671 6554196 6616818 6755603 6905634 01-030-40-0522 ALT XLE LNR NTRL G5 22 10885862549570 01-030-40-0528 ALT XLE LNR NTRL G5 28 10885862549587 01-030-40-0532 ALT XLE LNR NTRL G5 32 10885862549594 Serial Numbers: 6364123 6545007 6545009 6819586 6544984 6696804 6696813 6696831 6697228 6819605 6696824 6545005 6819552 6819555 6819626 6550155 6696797 6696829 6819560 6819602 6503912 6550154 6697209 6697219 6819546 6550163 6819547 6461311 6461317 6510348 6544983 6544986 6544997 6550125 6819623 6839298 6839307 6839319 01-030-40-0536 ALT XLE LNR NTRL G5 36 10885862549600 Serial Numbers: 6503060 6503079 6519872 6519884 6568438 6673873 6991788 7016132 7016133 6814014 7016138 7016171 7016190 6673490 6786747 6935467 6903070 6903091 6903894 6996086 6674288 7016140 6568363 6673505 7016121 6742757 6814011 6673865 6742736 6789560 6845867 6991774 6568373 6568379 6568408 6674282 6786691 6786711 6903049 6903310 6991777 6991787 01-030-40-0622 ALT XLE LNR NTRL G6 22 10885862549624 01-030-40-0628 ALT XLE LNR NTRL G6 28 10885862549631 01-030-40-0632 ALT XLE LNR NTRL G6 32 10885862549648 Serial Numbers: 6466438 6480096 6480097 6480189 6805461 6516596 6615504 6615514 6791742 6805492 6805494 6805506 6805472 6805467 6480187 6516585 6791753 6791762 6772337 6791740 6805489 6805493 6480094 6903173 6615534 6903147 6903148 6903149 6772328 6791733 6480194 6480198 6480199 6480201 6480204 6615516 6615535 6615538 6791752 6903171 01-030-40-0636 ALT XLE LNR NTRL G6 36 10885862549655 Serial Numbers: 6468227 6468233 6535823 6535843 6535850 6713969 6910948 7011763 6543766 6546688 6664517 6714000 6818737 6904146 6904183 6904247 6904263 6904265 6904279 6910942 6924396 6910933 7011781 7011787 7011799 6904187 6664538 6664556 6904180 6994087 7049691 6904175 6904211 6437314 6734823 6924338 6813951 6818697 6904145 6994107 6468595 6910967 6437378 6437320 6507461 6523299 6543771 6543779 6664528 6813988 6814006 6818694 6904264 6971001 6971018 01-030-40-0640 ALT XLE LNR NTRL G6 40 10885862549662 Serial Numbers: 6702678 6702682 6791334 7030144 6594793 6479757 6788453 6788463 6788465 6791332 6906373 6594774 6788474 7030174 6906381 6365250 6479746 6594759 6788448 6906296 6906352 01-030-40-0722 ALT XLE LNR NTRL G7 22 10885862549679 01-030-40-0728 ALT XLE LNR NTRL G7 28 10885862549686 01-030-40-0732 ALT XLE LNR NTRL G7 32 10885862549693 01-030-40-0736 ALT XLE LNR NTRL G7 36 10885862549709 Serial Numbers: 6498908 6498911 6546533 7011594 6546506 6740261 6818808 6818859 6826274 6828612 6903583 6936668 6818834 6936998 6937007 6937018 6818853 6734747 6437610 6631634 6826161 6828619 6826143 6828617 6936674 6398097 6437586 6437618 6546614 6826145 6734726 6818774 6398041 6936955 6546606 6818922 6936987 6398128 6937087 6437607 6479366 6546578 6546625 6557910 6557932 6734722 6742298 6742303 6818849 6903593 6904025 6936985 01-030-40-0740 ALT XLE LNR NTRL G7 40 10885862549716 Serial Numbers: 6560708 6999168 6512695 6904554 6566981 6755084 6787837 6904559 6788280 6364924 6711470 6788302 6904516 6904603 6904680 01-030-40-0822 ALT XLE LNR NTRL G8 22 10885862549723 01-030-40-0828 ALT XLE LNR NTRL G8 28 10885862549730 01-030-40-0832 ALT XLE LNR NTRL G8 32 10885862549747 01-030-40-0836 ALT XLE LNR NTRL G8 36 10885862549754 Serial Numbers: 6448197 6722244 6722254 6480837 6480845 6516431 6722241 6795481 6795507 6795513 6722441 6722451 6480835 6516437 6516456 6722440 6722459 6795493 6795498 6795500 6795522 6795523 6516424 6516438 6516444 6722247 6795495 6795496 6905059 6905050 6448219 6480833 6795505 6448209 6722239 6722255 6722446 6905042 6905056 6795517 6480841 6516462 6448199 6448201 6448220 6480842 6516434 6516443 6516446 6516447 6722245 6722258 6722443 6722445 6722455 6905040 6905336 6795529 6448200 6448215 6448216 6516454 6448202 6516460 6722252 6722453 6722456 6795506 6448204 6448205 6480838 6480844 6516429 6516449 6516465 6795485 6795488 6795492 6795515 6795527 01-030-40-0840 ALT XLE LNR NTRL G8 40 10885862549761 Serial Numbers: 6622368 6622399 6796199 6796208 6796209 6796215 6796217 6796219 6796230 6802728 6802724 6622394 6796200 6622376 6622384 6796197 6796240 6622378 6622400 6796234 6796218 6802711 6802709 6622379 6802722 6622370 6622383 6622391 6796212 6802723 6796205 01-030-42-0128 ALT XLE LNREXTCOV G1 28 10885862549792 Serial Numbers: 6673697 6673681 6673712 6904136 6673684 6673689 6673691 6673701 6673713 6673705 6673707 6673709 01-030-42-0228 ALT XLE LNR EXTCOV G2 28 10885862549815 Serial Numbers: 6714115 6714129 6714123 01-030-42-0232 ALT XLE LNR EXTCOV G2 32 10885862549822 Serial Numbers: 6467429 6271060 6818982 6819247 6434397 6434412 6819032 6600638 6722092 6600637 6722102 6434398 6434407 6516357 6600606 6819044 6819278 6845381 6819009 6819252 6819280 6819004 6936609 6516313 6600608 6819003 6516325 6722110 6600605 6845352 6818980 6819027 6819042 6467431 6516316 6516322 6600649 6600650 6722100 6845391 6600627 01-030-42-0328 ALT XLE LNR EXTCOV G3 28 10885862549846 Serial Number: 6798176 01-030-42-0332 ALT XLE LNR EXTCOV G3 32 10885862549853 Serial Numbers: 6850931 6920766 6466824 6732337 6732376 6848588 6920805 6270499 6732342 6634820 6732352 6732375 6850940 6634807 6797961 6480746 6516292 6528233 6528238 6797957 6848548 6920785 6920793 6721477 6848578 6850935 6920786 6732338 6850976 6850941 6797933 6848566 6480775 6848587 6797931 6797932 6920774 6732366 6797944 6797962 6920781 6516295 6721484 6721485 6732339 6732341 6848565 6848580 6850927 6920806 6480763 01-030-42-0428 ALT XLE LNR EXTCOV G4 28 10885862549884 01-030-42-0432 ALT XLE LNR EXTCOV G4 32 10885862549891 Serial Numbers: 6432101 6797247 6805374 6911167 6797285 6797163 6797250 6911205 6797255 6805389 6805402 6911173 6529122 6543940 6432096 6543945 6467452 6797251 6543933 6543943 6543950 01-030-42-0436 ALT XLE LNR EXTCOV G4 36 10885862549907 Serial Numbers: 6364434 6364446 6283904 6631841 6631893 6653249 6757771 6959472 6466911 6631910 6653248 6908912 6631860 6631885 6519500 6519528 6631839 6837081 6908920 6908929 6908905 6837072 6466920 6631859 6908914 6908915 6908928 6631897 6653236 6908965 6959441 6805519 6364439 6413433 6631867 6631881 6757739 6805520 6837094 6837115 6908873 6908907 6908932 6653250 01-030-42-0528 ALT XLE LNR EXTCOV G5 28 10885862549921 01-030-42-0532 ALT XLE LNR EXTCOV G5 32 10885862549938 Serial Numbers: 6697458 6798092 6915093 6915103 6584588 6798106 6926131 6798101 6798140 6926122 6584587 6584603 6697459 6798170 6915101 6915132 6584602 6926145 6697445 6798081 6697430 6798122 6432151 6915125 6926144 01-030-42-0536 ALT XLE LNR EXTCOV G5 36 10885862549945 Serial Numbers: 6363292 6334967 6679897 6820596 6919979 6845791 6926206 6432165 6461785 6570250 6820413 6845781 6919976 6680463 6926210 6679811 6820378 6820597 6920048 6363300 6679900 6845793 6920034 6570270 6680494 6467913 6480966 6926173 6926197 6926186 6820570 6480976 6598993 6598994 6679917 6845759 6920001 6920106 6926180 6679929 01-030-42-0628 ALT XLE LNR EXTCOV G6 28 10885862549976 01-030-42-0632 ALT XLE LNR EXTCOV G6 32 10885862549983 Serial Numbers: 6584891 6584908 6678841 6843076 6678818 6798738 6678705 6678854 6584909 6584912 6798716 6798730 6805306 6843059 6678856 6798718 6466987 6466993 6584886 6678821 6678832 6678852 6911542 6251501 01-030-42-0636 ALT XLE LNR EXTCOV G6 36 10885862549990 Serial Numbers: 6367048 6467231 6514059 6664382 6822278 6974766 6367047 6432135 6822262 6432147 6919693 6664407 6719853 6822247 6822264 6838554 6860932 6919698 6514041 6974765 6838563 6860935 6719857 6919676 6860964 6664377 6664378 6719851 6514071 6514087 6719834 6822260 6822285 6860956 6838559 01-030-42-0640 ALT XLE LNR EXTCOV G6 40 10885862550002 Serial Numbers: 6796566 6478165 6478167 6481056 6602457 6796560 6979875 6979881 6481052 6796595 6602485 6602487 6602461 6602486 6602496 6723618 6723622 6796575 6796589 6723648 6723652 6979855 6478169 6478178 6602465 6905158 6905166 6979869 6602467 6723627 6905174 6905193 6602488 01-030-42-0728 ALT XLE LNR EXTCOV G7 28 10885862550026 01-030-42-0732 ALT XLE LNR EXTCOV G7 32 10885862550033 Serial Number: 6534394 01-030-42-0736 ALT XLE LNR EXTCOV G7 36 10885862550040 Serial Numbers: 6434417 6528290 6914968 6434430 6434431 6820745 6702752 6528293 6925964 6563680 6563684 6702744 6820730 6911446 6703093 6702741 6911445 6519422 6519429 6528284 6911429 6911435 01-030-42-0740 ALT XLE LNR EXTCOV G7 40 10885862550057 Serial Numbers: 6435829 6435813 6532693 6773661 6664430 6664441 6664461 6664427 6773643 6773644 6773648 6914439 6773657 6773658 6805588 6805600 6980417 6914442 6980426 6980431 6980440 6980443 6914406 01-030-42-0828 ALT XLE LNR EXTCOV G8 28 10885862550071 01-030-42-0832 ALT XLE LNR EXTCOV G8 32 10885862550088 01-030-42-0836 ALT XLE LNR EXTCOV G8 36 10885862550095 Serial Numbers: 6544263 6789025 6480825 6674452 6674465 6674469 6788981 6789050 6789055 6789064 6789002 6789029 6480820 6544258 6544260 6674446 6674478 6674481 6674483 6788979 6789022 6789048 6789056 6789058 6926001 6926010 6674453 6788969 6789044 6674468 6674472 6674486 6788988 6926024 6674470 6674487 6789033 6480800 6926003 6674471 6674482 6788972 6789009 6480809 6789008 6480815 6480826 6544268 6674445 6674456 6674476 6788990 6926027 01-030-42-0840 ALT XLE LNR EXTCOV G8 40 10885862550101 Serial Numbers: 6467813 6730678 6842054 6842055 6842056 6842078 6842061 6730667 6842040 6563802 6563816 6563800 6730643 6730656 6730660 6730665 6730670 6842058 6467819 6503084 6842067 6730645 6730663 6842043 6842080 6842035 6842046 6842070 6503086 6563810 6730642 6842077 6563815 01-030-46-0022 ALT XLE LNR+5 LAT G0 22 10885862550453 01-030-46-0128 ALT XLE LNR+5 LAT G1 28 10885862550477 Serial Numbers: 6900600 6900601 6900602 6900615 01-030-46-0232 ALT XLE LNR+5 LAT G2 32 10885862550507 Serial Numbers: 6635087 6850987 6851017 6851019 6406775 6406787 6635090 6635093 6635100 6850998 6850983 6635081 6635089 6851012 6635054 6635062 6850993 6468221 6468222 6406784 6635059 6468218 6498778 6498767 6635091 01-030-46-0332 ALT XLE LNR+5 LAT G3 32 10885862550538 Serial Numbers: 6583075 6819376 6903978 6903979 6270603 6583072 6583083 6583092 6583100 6819377 6583097 6819360 6583073 6583077 6583081 6819378 6583104 6583105 6819347 01-030-46-0432 ALT XLE LNR+5 LAT G4 32 10885862550576 Serial Numbers: 6519888 6519891 6798186 6839614 6839628 6798187 6839612 6798191 6839625 6452675 6452677 6798205 6839603 6839618 6798204 6798208 6839602 6798181 6798206 6798182 6839629 01-030-46-0436 ALT XLE LNR+5 LAT G4 36 10885862550583 Serial Numbers: 6515473 6817368 6817380 6817389 6817432 6817450 6515455 6583533 6583535 6515467 6583528 6583538 6817381 6515461 6817373 6583537 6817412 6817414 6817364 6817374 6817449 6817371 6817413 6817419 6817426 6515450 6515464 01-030-46-0532 ALT XLE LNR+5 LAT G5 32 10885862550613 Serial Numbers: 6796129 6473893 6473903 6796161 6926319 6926320 6796124 6796130 6796119 6473894 6796134 6926308 6926314 01-030-46-0536 ALT XLE LNR+5 LAT G5 36 10885862550620 Serial Numbers: 6435975 6435976 6826204 6826225 6840355 6840359 6435981 6514567 6514530 6514532 6514534 6514542 6435967 6826188 6840373 6826223 6840383 6514541 6514545 6826218 6826227 6826226 6435962 6435978 6514562 6514552 01-030-46-0632 ALT XLE LNR+5 LAT G6 32 10885862550668 Serial Numbers: 6726493 6912498 6912506 6474457 6912465 6726469 6726478 6726472 6474445 6726494 01-030-46-0636 ALT XLE LNR+5 LAT G6 36 10885862550675 Serial Numbers: 6819186 6819190 6819193 6819196 6913441 6819206 6364503 6593496 6593497 6926078 6926098 6819220 6503312 6593494 6819232 6819185 6819187 6913432 6364521 6544676 6544687 6913434 6593501 01-030-46-0640 ALT XLE LNR+5 LAT G6 40 10885862550682 Serial Numbers: 6653265 6992017 6992019 6653284 6653286 6653267 6653278 6653283 6653285 6992015 6992022 6653299 01-030-46-0736 ALT XLE LNR+5 LAT G7 36 10885862550729 Serial Numbers: 6819853 6919184 6919187 6919204 6919205 6519462 6519479 6519445 6519465 6819883 6919181 6919213 6819855 6919209 6519475 6919180 6919198 6919212 6819873 6819880 6819858 6519439 6519456 6819845 6819863 6819865 01-030-46-0740 ALT XLE LNR+5 LAT G7 40 10885862550736 Serial Numbers: 6679145 6906261 6906277 6906286 6679100 6679105 6906288 6679139 6926221 6926231 6926236 6679129 6679143 6906278 6906281 6679124 01-030-46-0836 ALT XLE LNR+5 LAT G8 36 10885862550774 Serial Numbers: 6679497 6679509 6679511 6679521 6679485 6679487 6915190 6915196 6679515 6679480 6679486 6679494 6679504 6679522 6679491 6915193 6679490 6679496 01-030-46-0840 ALT XLE LNR+5 LAT G8 40 10885862550781 Serial Numbers: 6683545 6683536 6904339 6904346 6925644 6683557 6683546 6683540 6683560 6683552 6904344 6925648 01-030-48-0128 ALT XLE LNR10¿ FC G1 28 10885862550811 01-030-48-0232 ALT XLE LNR 10¿ FC G2 32 10885862550842 Serial Numbers: 6923145 6155940 6566979 6503385 6503379 6915426 6795591 6566967 6795560 6795566 6566969 6503390 6795562 01-030-48-0332 ALT XLE LNR 10¿ FC G3 32 10885862550873 Serial Numbers: 6843398 6843426 6503045 6564408 6476967 6476973 6564405 6843394 6843395 6503044 6678549 6678544 6503049 6678547 ***** 01-030-48-0432 ALT XLE LNR 10 FC G4 32 Serial Numbers: 6974655 6467206 6818908 6474717 6818900 6474716 6474733 6974661 ***** 01-030-48-0436 ALT XLE LNR 10¿ FC G4 36 10885862550927 Serial Numbers: 6817258 6516566 6817270 6481827 6817294 6481828 6516546 6516557 6817301 6817305 6516565 6516572 6481837 6817245 6516545 6817259 01-030-48-0532 ALT XLE LNR 10¿ FC G5 32 10885862550958 Serial Numbers: 6820038 6482096 6820026 6820044 6820058 6563818 6563825 6820019 01-030-48-0536 ALT XLE LNR 10¿ FC G5 36 10885862550965 Serial Numbers: 6721997 6525547 6803892 6166094 6525555 6721992 6480721 6480724 6721982 7018686 6803904 6480745 6803900 6480731 6803888 6803896 6466834 01-030-48-0632 ALT XLE LNR 10¿ FC G6 32 10885862551009 Serial Numbers: 6819325 6519052 6819292 6819297 6819316 01-030-48-0636 ALT XLE LNR 10¿ FC G6 36 10885862551016 Serial Numbers: 6905829 6503282 6503292 6566586 6926260 6165865 6788048 6566591 6905814 6788044 6788021 6788029 6566596 6566599 01-030-48-0640 ALT XLE LNR 10¿ FC G6 40 10885862551023 Serial Numbers: 6795619 6795643 01-030-48-0736 ALT XLE LNR 10¿ FC G7 36 10885862551061 Serial Numbers: 6914060 6517396 6914062 6165770 6914044 6914072 6517367 6517369 6517380 6466947 6517364 6789758 6517397 6517385 6789755 01-030-48-0740 ALT XLE LNR 10¿ FC G7 40 10885862551078 Serial Numbers: 6842122 6842137 6842148 6798979 01-030-48-0836 ALT XLE LNR 10¿ FC G8 36 10885862551115 Serial Numbers: 6752166 6752182 6752185 6752189 6752194 6752191 6752163 6752170 6752159 01-030-48-0840 ALT XLE LNR 10¿ FC G8 40 10885862551122 Serial Numbers: 6904115 6597559 6904121 6904126
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 Nw 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Matthew Collins; 352-377-1140
• Manufacturer Reason for Recall: Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 12/31/2024, the firm sent an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" letter via FedEx to customers initially informing them that the firm was recalling specific hip polyethylene liner lots that were inadvertently packaged without the ethylene vinyl alcohol (EVOH) layer in the innermost bag. An updated customer notification letter was communicated to affected customer via email on 01/17/2025. Customers are instructed to: -Immediate Discontinuation: Immediately discontinue use of all affected products -Quarantine and Return: Segregate and quarantine affected products and arrange for their return to Exactech. The Recall Confirmation Form section of this communication provides product return instructions. Clinical Guidance: 1. Patient Monitoring: Surgeons should regularly monitor patients with affected devices for potential risks such as device wear, failure, component cracking or fracture, new or worsening pain, bone loss and/or swelling, as per the instructions for use. 2. Diagnostic Considerations: Diagnostic imaging, such as X-rays, may be considered if device failure is suspected. 3. Revision Considerations: Revision of well-functioning devices is not recommended for patients. 4. Resources: Healthcare providers and patients with questions can access educational resources on our website exac.com/recall-information and use the device serial look-up tool. Public Contact - 352-377-1140 or email matt.collins@exac.com
• Quantity in Commerce: 1446
• Distribution: U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK, PR,SC, TN, TX and VA O.U.S.: Argentina, Colombia, Germany, Guatemala, Japan and Spain
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LPH