Reported Feb 19, 2025 · Ongoing
Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 22MM 140-28-50 NV EHXLNTRL LNR G0 28MM…
Exactech, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Exactech, Inc. · 2320 Nw 66th Ct · Gainesville, FL · 32653-1630
Is this the product you have?
- Alteon
- XLE Item Number / Product Description140-22-70 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
- Lot codes and dates
- Item Number /
- Product Description/ UDI-DI code01-030-40-0022 ALT XLE LNRNTRL
- G0 22 10885862549433 Serial NumbersALT XLE LNRNTRL G1 22 10885862549440 01-030-40-0128 ALT XLE LNR NTRL
677145367714606771467677148467714586771456677146867714796771444677146167714706771474677148101-030-40-0122
- G1 28 10885862549457 Serial NumbersALT XLE LNRNTRL G2 22 10885862549464 01-030-40-0228 ALT XLE LNR NTRL
6515426651543467501406750151659739965974106750127675013267501456906249651544065974076597409651544365973986597408651542867501526597400651544165154426597403675016469062416906245690625801-030-40-0222
- G2 28 10885862549471 Serial Numbers6532932 6532935 01-030-40-0232 ALT XLE LNR NTRL
- G2 32 10885862549488 Serial NumbersALT XLE LNR NTRL G3 22 10885862549495 01-030-40-0328 ALT XLE LNR NTRL
73 of 73 codes
690461664360036486043651297065129726592041659205268385726838573683862969044666904461660227966023146602327671222068263246477677647768266023036712155671222168386566904499690460664860406486053701039068385776838636683865169044866477683647771769044936712152682629368386187010361690449565920406602310671216765920606602294683864867121536712209660231667121716838622643600464776946512971660230468262906826296682630368386406486034
- G3 28 10885862549501 Serial Numbers6532515 6532527 01-030-40-0332 ALT XLE LNR NTRL
- G3 32 10885862549518 Serial NumbersALT 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
6513473643205365134876589221690372569258386925842661298566698346745989649881666786556678691674600569258826903708690374569037876834322700996470099896668617677508468261336925826692580864826396668602692582969258696826117651347863699296369932651352265135246903800648264569037496903785682609968261326834318690375769047326904742648263664978466513498651351666129556826116682612468261296904706692580701-030-40-0422
- G4 32 10885862549556 Serial NumbersALT XLE LNR NTRL
65190786519107663175967259466725905672592567259336725983681909868448666819097673224767259186725984681911969244786725907672592367322646819143684488264811006732222681913462707546481105651909665683426725912672597467322496924246692449001-030-40-0436
- G4 36 10885862549563 Serial NUmbersALT 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
650414465041496510663651066965541467030120679799270300446798003667390767911577030084690552569056106905742679800567980187030114679799763664756510671655419666168186755603690563401-030-40-0522
- G5 32 10885862549594 Serial NumbersALT XLE LNR NTRL
6364123654500765450096819586654498466968046696813669683166972286819605669682465450056819552681955568196266550155669679766968296819560681960265039126550154669720966972196819546655016368195476461311646131765103486544983654498665449976550125681962368392986839307683931901-030-40-0536
- G5 36 10885862549600 Serial NumbersALT 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
65030606503079651987265198846568438667387369917887016132701613368140147016138701617170161906673490678674769354676903070690309169038946996086667428870161406568363667350570161216742757681401166738656742736678956068458676991774656837365683796568408667428267866916786711690304969033106991777699178701-030-40-0622
- G6 32 10885862549648 Serial NumbersALT XLE LNR NTRL
646643864800966480097648018968054616516596661550466155146791742680549268054946805506680547268054676480187651658567917536791762677233767917406805489680549364800946903173661553469031476903148690314967723286791733648019464801986480199648020164802046615516661553566155386791752690317101-030-40-0636
- G6 36 10885862549655 Serial NumbersALT XLE LNR NTRL
646822764682336535823653584365358506713969691094870117636543766654668866645176714000681873769041466904183690424769042636904265690427969109426924396691093370117817011787701179969041876664538666455669041806994087704969169041756904211643731467348236924338681395168186976904145699410764685956910967643737864373206507461652329965437716543779666452868139886814006681869469042646971001697101801-030-40-0640
- G6 40 10885862549662 Serial NumbersALT 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
67026786702682679133470301446594793647975767884536788463678846567913326906373659477467884747030174690638163652506479746659475967884486906296690635201-030-40-0722
- G7 36 10885862549709 Serial NumbersALT XLE LNR NTRL
649890864989116546533701159465465066740261681880868188596826274682861269035836936668681883469369986937007693701868188536734747643761066316346826161682861968261436828617693667463980976437586643761865466146826145673472668187746398041693695565466066818922693698763981286937087643760764793666546578654662565579106557932673472267422986742303681884969035936904025693698501-030-40-0740
- G7 40 10885862549716 Serial NumbersALT 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
65607086999168651269569045546566981675508467878376904559678828063649246711470678830269045166904603690468001-030-40-0822
- G8 36 10885862549754 Serial NumbersALT XLE LNR NTRL
81 of 81 codes
644819767222446722254648083764808456516431672224167954816795507679551367224416722451648083565164376516456672244067224596795493679549867955006795522679552365164246516438651644467222476795495679549669050596905050644821964808336795505644820967222396722255672244669050426905056679551764808416516462644819964482016448220648084265164346516443651644665164476722245672225867224436722445672245569050406905336679552964482006448215
- G8 40 10885862549761 Serial NumbersALT XLE LNREXTCOV
662236866223996796199679620867962096796215679621767962196796230680272868027246622394679620066223766622384679619767962406622378662240067962346796218680271168027096622379680272266223706622383662239167962126802723679620501-030-42-0128
- G1 28 10885862549792 Serial NumbersALT XLE LNR EXTCOV
66736976673681667371269041366673684667368966736916673701667371366737056673707667370901-030-42-0228
- G2 28 10885862549815 Serial Numbers6714115 6714129 6714123 01-030-42-0232 ALT XLE LNR EXTCOV
- G2 32 10885862549822 Serial NumbersALT XLE LNR EXTCOV
6467429627106068189826819247643439764344126819032660063867220926600637672210264343986434407651635766006066819044681927868453816819009681925268192806819004693660965163136600608681900365163256722110660060568453526818980681902768190426467431651631665163226600649660065067221006845391660062701-030-42-0328
- G3 28 10885862549846 Serial Number6798176 01-030-42-0332 ALT XLE LNR EXTCOV
- G3 32 10885862549853 Serial NumbersALT XLE LNR EXTCOV G4 28 10885862549884 01-030-42-0432 ALT XLE LNR EXTCOV
68509316920766646682467323376732376684858869208056270499673234266348206732352673237568509406634807679796164807466516292652823365282386797957684854869207856920793672147768485786850935692078667323386850976685094167979336848566648077568485876797931679793269207746732366679794467979626920781651629567214846721485673233967323416848565684858068509276920806648076301-030-42-0428
- G4 32 10885862549891 Serial NumbersALT XLE LNR EXTCOV
64321016797247680537469111676797285679716367972506911205679725568053896805402691117365291226543940643209665439456467452679725165439336543943654395001-030-42-0436
- G4 36 10885862549907 Serial NumbersALT XLE LNR EXTCOV G5 28 10885862549921 01-030-42-0532 ALT XLE LNR EXTCOV
6364434636444662839046631841663189366532496757771695947264669116631910665324869089126631860663188565195006519528663183968370816908920690892969089056837072646692066318596908914690891569089286631897665323669089656959441680551963644396413433663186766318816757739680552068370946837115690887369089076908932665325001-030-42-0528
- G5 32 10885862549938 Serial NumbersALT XLE LNR EXTCOV
669745867980926915093691510365845886798106692613167981016798140692612265845876584603669745967981706915101691513265846026926145669744567980816697430679812264321516915125692614401-030-42-0536
- G5 36 10885862549945 Serial NumbersALT XLE LNR EXTCOV G6 28 10885862549976 01-030-42-0632 ALT XLE LNR EXTCOV
636329263349676679897682059669199796845791692620664321656461785657025068204136845781691997666804636926210667981168203786820597692004863633006679900684579369200346570270668049464679136480966692617369261976926186682057064809766598993659899466799176845759692000169201066926180667992901-030-42-0628
- G6 32 10885862549983 Serial NumbersALT XLE LNR EXTCOV
65848916584908667884168430766678818679873866787056678854658490965849126798716679873068053066843059667885667987186466987646699365848866678821667883266788526911542625150101-030-42-0636
- G6 36 10885862549990 Serial NumbersALT XLE LNR EXTCOV
6367048646723165140596664382682227869747666367047643213568222626432147691969366644076719853682224768222646838554686093269196986514041697476568385636860935671985769196766860964666437766643786719851651407165140876719834682226068222856860956683855901-030-42-0640
- G6 40 10885862550002 Serial NumbersALT XLE LNR EXTCOV G7 28 10885862550026 01-030-42-0732 ALT XLE LNR EXTCOV
67965666478165647816764810566602457679656069798756979881648105267965956602485660248766024616602486660249667236186723622679657567965896723648672365269798556478169647817866024656905158690516669798696602467672362769051746905193660248801-030-42-0728
- G7 32 10885862550033 Serial Number6534394 01-030-42-0736 ALT XLE LNR EXTCOV
- G7 36 10885862550040 Serial NumbersALT XLE LNR EXTCOV
643441765282906914968643443064344316820745670275265282936925964656368065636846702744682073069114466703093670274169114456519422651942965282846911429691143501-030-42-0740
- G7 40 10885862550057 Serial NumbersALT 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
6435829643581365326936773661666443066644416664461666442767736436773644677364869144396773657677365868055886805600698041769144426980426698043169804406980443691440601-030-42-0828
- G8 36 10885862550095 Serial NumbersALT XLE LNR EXTCOV
6544263678902564808256674452667446566744696788981678905067890556789064678900267890296480820654425865442606674446667447866744816674483678897967890226789048678905667890586926001692601066744536788969678904466744686674472667448667889886926024667447066744876789033648080069260036674471667448267889726789009648080967890086480815648082665442686674445667445666744766788990692602701-030-42-0840
- G8 40 10885862550101 Serial NumbersALT XLE LNR+5 LAT G0 22 10885862550453 01-030-46-0128 ALT XLE LNR+5
64678136730678684205468420556842056684207868420616730667684204065638026563816656380067306436730656673066067306656730670684205864678196503084684206767306456730663684204368420806842035684204668420706503086656381067306426842077656381501-030-46-0022
- LAT G1 28 10885862550477 Serial Numbers6900600 6900601 6900602 6900615 01-030-46-0232 ALT XLE LNR+5
- LAT G2 32 10885862550507 Serial NumbersALT XLE LNR+5
663508768509876851017685101964067756406787663509066350936635100685099868509836635081663508968510126635054663506268509936468221646822264067846635059646821864987786498767663509101-030-46-0332
- LAT G3 32 10885862550538 Serial NumbersALT XLE LNR+5
658307568193766903978690397962706036583072658308365830926583100681937765830976819360658307365830776583081681937865831046583105681934701-030-46-0432
- LAT G4 32 10885862550576 Serial NumbersALT XLE LNR+5
65198886519891679818668396146839628679818768396126798191683962564526756452677679820568396036839618679820467982086839602679818167982066798182683962901-030-46-0436
- LAT G4 36 10885862550583 Serial NumbersALT XLE LNR+5
65154736817368681738068173896817432681745065154556583533658353565154676583528658353868173816515461681737365835376817412681741468173646817374681744968173716817413681741968174266515450651546401-030-46-0532
- LAT G5 32 10885862550613 Serial NumbersALT XLE LNR+5
679612964738936473903679616169263196926320679612467961306796119647389467961346926308692631401-030-46-0536
- LAT G5 36 10885862550620 Serial NumbersALT XLE LNR+5
6435975643597668262046826225684035568403596435981651456765145306514532651453465145426435967682618868403736826223684038365145416514545682621868262276826226643596264359786514562651455201-030-46-0632
- LAT G6 32 10885862550668 Serial NumbersALT XLE LNR+5
672649369124986912506647445769124656726469672647867264726474445672649401-030-46-0636
- LAT G6 36 10885862550675 Serial NumbersALT XLE LNR+5
6819186681919068191936819196691344168192066364503659349665934976926078692609868192206503312659349468192326819185681918769134326364521654467665446876913434659350101-030-46-0640
- LAT G6 40 10885862550682 Serial NumbersALT XLE LNR+5
66532656992017699201966532846653286665326766532786653283665328569920156992022665329901-030-46-0736
- LAT G7 36 10885862550729 Serial NumbersALT XLE LNR+5
6819853691918469191876919204691920565194626519479651944565194656819883691918169192136819855691920965194756919180691919869192126819873681988068198586519439651945668198456819863681986501-030-46-0740
- LAT G7 40 10885862550736 Serial NumbersALT XLE LNR+5
667914569062616906277690628666791006679105690628866791396926221692623169262366679129667914369062786906281667912401-030-46-0836
- LAT G8 36 10885862550774 Serial NumbersALT XLE LNR+5
66794976679509667951166795216679485667948769151906915196667951566794806679486667949466795046679522667949169151936679490667949601-030-46-0840
- LAT G8 40 10885862550781 Serial NumbersALT XLE LNR10¿ FC G1 28 10885862550811 01-030-48-0232 ALT XLE LNR 10¿
66835456683536690433969043466925644668355766835466683540668356066835526904344692564801-030-48-0128
- FC G2 32 10885862550842 Serial NumbersALT XLE LNR 10¿
692314561559406566979650338565033796915426679559165669676795560679556665669696503390679556201-030-48-0332
- FC G3 32 10885862550873 Serial Numbers***** 01-030-48-0432
68433986843426650304565644086476967647697365644056843394684339565030446678549667854465030496678547
- ALT XLE LNR 10 FC G4 32 Serial Numbers***** 01-030-48-0436 ALT XLE LNR 10¿
69746556467206681890864747176818900647471664747336974661
- FC G4 36 10885862550927 Serial NumbersALT XLE LNR 10¿
681725865165666817270648182768172946481828651654665165576817301681730565165656516572648183768172456516545681725901-030-48-0532
- FC G5 32 10885862550958 Serial NumbersALT XLE LNR 10¿
6820038648209668200266820044682005865638186563825682001901-030-48-0536
- FC G5 36 10885862550965 Serial NumbersALT XLE LNR 10¿
6721997652554768038926166094652555567219926480721648072467219827018686680390464807456803900648073168038886803896646683401-030-48-0632
- FC G6 32 10885862551009 Serial Numbers6819325 6519052 6819292 6819297 6819316 01-030-48-0636 ALT XLE LNR 10¿
- FC G6 36 10885862551016 Serial NumbersALT XLE LNR 10¿
6905829650328265032926566586692626061658656788048656659169058146788044678802167880296566596656659901-030-48-0640
- FC G6 40 10885862551023 Serial Numbers6795619 6795643 01-030-48-0736 ALT XLE LNR 10¿
- FC G7 36 10885862551061 Serial NumbersALT XLE LNR 10¿
69140606517396691406261657706914044691407265173676517369651738064669476517364678975865173976517385678975501-030-48-0740
- FC G7 40 10885862551078 Serial Numbers6842122 6842137 6842148 6798979 01-030-48-0836 ALT XLE LNR 10¿
- FC G8 36 10885862551115 Serial NumbersALT XLE LNR 10¿
67521666752182675218567521896752194675219167521636752170675215901-030-48-0840
- FC G8 40 10885862551122 Serial Numbers6904115 6597559 6904121 6904126
- Amount recalled
- 1446
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
This product could cause temporary or reversible health problems — stop using it.
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