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U.S. Department of Health and Human Services

Class 2 Device Recall Brasseler ESR

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 Class 2 Device Recall Brasseler ESRsee related information
Date Initiated by FirmJanuary 02, 2025
Date PostedFebruary 06, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1114-2025
Recall Event ID 95776
Product Classification File, pulp canal, endodontic - Product Code EKS
ProductBrasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK AP135253PK AP135313PK AP145213PK AP145253PK AP145313PK AP1GP213PK AP1GP253PK AP1GP313PK O.U.S. Products: EdgeFile X7 REF: SX70421MM SX70425MM SX70429MM SX70621MM SX70625MM SX70629MM SX7170421RF SX7170425RF SX7170429RF SX7170621RF SX7170625RF SX7170629RF SX7200421RF SX7200425RF SX7200429RF SX7200621RF SX7200625RF SX7200629RF SX7250421RF SX7250425RF SX7250429RF SX7250621RF SX7250625RF SX7250629RF SX7300421RF SX7300425RF SX7300429RF SX7300621RF SX7300625RF SX7300629RF SX7350421RF SX7350425RF SX7350429RF SX7350621RF SX7350625RF SX7350629RF SX7400421RF SX7400425RF SX7400429RF SX7400621RF SX7400625RF SX7400629RF SX7450421RF SX7450425RF SX7450429RF SX7450621RF SX7450625RF SX7450629RF EdgeGlidePath REF: SEGP0221 SEGP0225 SEGP0231 EdgeOne Fire REF: SEOFAST21 SEOFAST25 SEOFAST31 SEOFLG21 SEOFLG25 SEOFLG31 SEOFMED21 SEOFMED25 SEOFMED31 SEOFPRI21 SEOFPRI25 SEOFPRI31 SEOFSM21 SEOFSM25 SEOFSM31 EdgeOne Fire GlidePath REF: SEOFGP21 SEOFGP25 SEOFGP31 EdgeTaper REF: SET21MM SET25MM SET31MM SETF121 SETF125 SETF131 SETF221 SETF225 SETF231 SETF321 SETF325 SETF331 SETF421 SETF425 SETF431 SETF521 SETF525 SETF531 SETS121 SETS125 SETS131 SETS221 SETS225 SETS231 SETSX19 EdgeTaper Platinum REF: SETF121HT SETF125HT SETF131HT SETF221HT SETF225HT SETF231HT SETF321HT SETF325HT SETF331HT SETF421HT SETF425HT SETF431HT SETF521HT SETF525HT SETF531HT SETP21MM SETP25MM SETP31MM SETS121HT SETS125HT SETS131HT SETS221HT SETS225HT SETS231HT SETSX19HT EdgeSequel Sapphire REF: SES150421 SES150425 SES150625 SES150631 SES200421 SES200425 SES200621 SES200625 SES200631 SES250421 SES250425 SES250621 SES250625 SES250821 SES250825 SES250831 SES300421 SES300425 SES300621 SES300625 SES300631 SES350421 SES350425 SES350431 SES350621 SES350625 SES400421 SES400425 SES400625 SES400631 SES450421 SES450425 SES450431 SES450631 SES500421 SES500431 SES500625 SES550421 SES550425 SES600421 SES600425 SES600431 SES700421 SES700425 SES800425 SES900425 SESSAST0421 SESSAST0421L SESSAST0425 SESSAST0425L SESSAST0431 SESSAST0431L SESSAST0621 SESSAST0625 SESSAST0631 SESSAST0631L Endodontic files are intended to be used to clean, shape, and debride the root canal system.
Code Information Device SKU / GTIN code AP120213PK / 00887919811343 Lot Numbers: 020222033 042624005 060320018 060420001 070820001 071321009 071321010 080523075 111819267 AP120253PK / 00887919811374 Lot Numbers: 042821235 042821235 042821236 042821236 042821238 051024026 051423101 051423102 060420003 060420004 063020331 063020332 063020333 080321003 080321004 080523077 080523078 101821059 101821060 101821061 101821062 101821063 120219105 121120218 121120221 121120222 121120223 AP120313PK / 00887919811404 Lot Number: 110821062 AP125213PK / 00887919811435 Lot Numbers: 021920313 030222002 030320002 041423016 072320011 101821056 101821057 101821058 111220210 111220211 111220212 111220213 111220214 121119001 AP125253PK / 00887919811466 Lot Numbers: 010622001 012121085 012121086 012121087 012121088 012121089 012121090 012121091 012121092 021920315 031620090 031620091 031620092 041224032 041224033 051221001 051221600 051423103 051423104 061620001 061620002 062323152 062323153 062921149 062921150 072721067 072721068 080523079 080523080 080523081 090220016 090220018 090220019 101821064 101821066 101821069 121521017 121521018 121521019 AP125313PK / 00887919811497 Lot Numbers: 030221289 050324127 061620004 080420319 AP135213PK / 00887919811527 Lot Numbers: 030221290 080523076 110821061 121521020 AP135253PK / 00887919811558 Lot Numbers: 040522008 040522009 081723036 081723037 120619106 061120031 072320012 080520055 AP135313PK / 00887919811589 Lot Number: 032322001 AP145213PK / 00887919811619 Lot Numbers: 090321002 090920028 111121040 AP145253PK / 00887919811640 Lot Numbers: 011322052 011322053 040120068 050324126 061620003 072320013 080420318 081123086 111220215 111220217 111220218 111220219 121119002 AP145313PK / 00887919811671 Lot Numbers: 031620093 040522010 AP1GP213PK / 00887919811701 Lot Numbers: 090920027 010721055 080321001 101821053 101821054 101821055 AP1GP253PK / 00887919811732 Lot Numbers: 012522001 041224031 051221002 052021052 052021053 052021054 052021055 052021056 060420002 080420317 090220011 090220013 090220015 111819268 AP1GP313PK / 00887919811763 Lot Numbers: 012221001 062022041 O.U.S. product information EdgeFile X7 REF: SX70421MM / 00810047641995 Lot Numbers: 110421040 120221077 120820037 012121140 012622038 012822018 021021334 030521027 030821036 041221418 042221189 042221250 052421036 052621007 042823044 111021079 SX70425MM / 00810047642008 Lot Numbers: 111121037 121421023 121621178 122021018 123021036 123021043 011322185 011322186 011322187 011322204 012121139 012522008 012822012 020222111 021021335 022322010 030521028 030821035 030821228 032221374 041221419 042221190 042221249 050422014 050422015 050422055 050422056 051221005 052021015 012822492 042823045 061823139 062323219 111621075 SX70429MM / 00810047642015 Lot Numbers: 012121138 012822308 021021336 030521029 030821034 032221375 041221420 051721273 111621076 SX70621MM / 00810047642022 Lot Numbers: 123021037 012121137 012822309 021021337 030521030 041221421 042221248 052421037 111021082 111621077 SX70625MM / 00810047642039 Lot Numbers: 121621179 012121136 012822310 021021338 030521031 030521149 030521183 032221376 041221422 042221247 050721024 051221006 052021016 052421038 052421039 080921048 092021061 012822494 050224011 111621078 SX70629MM / 00810047642046 Lot Numbers: 120820043 012121135 030521032 030521148 032221377 041221423 051221007 052021017 052421040 070121048 051721276 012822495 111021084 111621079 SX7170421RF / 00810047641544 Lot Numbers: 120820155 121120287 012121125 012822292 013022001 020222052 032221339 042221037 042221231 050324064 051423001 052421007 120221037 012822496 012822607 062323220 050224012 050524008 111021085 SX7170425RF / 00810047641551 Lot Numbers: 110421037 120820157 121120288 121421019 121621174 122921113 123021026 123021030 123021052 012121124 012622158 012822293 013022002 013022218 020222053 022322002 022622349 030521222 032221340 042221036 050324056 050422004 050422061 051423002 051423006 051423007 052421008 061823011 070323025 070323026 070323027 092021068 071621015 081721021 012822608 071422056 072822033 081122027 082622032 042823046 050623073 061023124 061823140 062323221 050224013 050524009 071422057 SX7170429RF / 00810047641568 Lot Numbers: 120820159 121120289 122921114 012121126 030521023 032221341 052021009 052421009 012822609 111021088 111621083 SX7170621RF / 00810047641575 Lot Numbers: 120820160 121120290 012121127 013022024 022622352 030521022 032221342 042221035 042221232 052421010 012822610 050224014 111021089 111621084 SX7170625RF / 00810047641582 Lot Numbers: 120820161 121120291 012121128 012222117 012222118 012622159 013022025 030521021 030521035 032221343 042221034 042221209 050422030 050721019 052421011 012822611 SX7170629RF / 00810047641599 Lot Numbers: 120820162 121120292 030521020 030521036 032221344 052421012 012822612 111021091 SX7200421RF / 00810047641605 Lot Numbers: 120820163 121120293 012121130 030521019 030521037 032221345 042221033 051024013 052021010 011322046 012822613 072822034 072822035 111021092 111021093 SX7200425RF / 00810047641612 Lot Numbers: 120820164 121120294 121421020 123021027 012121131 012222119 012222120 012822295 021021319 030521018 030521038 032221346 042221032 050324055 050422005 050422006 050422031 050422060 051024014 092021066 071422058 081122028 082622033 050623074 051423017 061023125 061823141 061823142 062323222 050224015 050524010 111621089 111621090 072822036 SX7200429RF / 00810047641629 Lot Numbers: 120820001 121120295 012121600 012622161 022622359 030521017 030521039 032221347 051024015 012822615 062323223 111021098 111621091 SX7200621RF / 00810047641636 Lot Numbers: 120820002 121120296 123021051 012121133 030521016 030521040 032221348 042221031 042221178 050422059 052421013 070323021 012822616 081122029 082622034 062323224 SX7200625RF / 00810047641643 Lot Numbers: 120820003 121120297 121621175 012121134 012222121 012622163 012822296 013022028 022622362 030521015 030521041 032221349 042221030 042221179 050422032 051024016 052021011 052421014 052421015 012822245 012822617 012822499 051522029 071422059 072822037 081122030 082622035 051423018 061023126 062323225 080523038 050224016 111021601 111621600 SX7200629RF / 00810047641650 Lot Numbers: 120820004 120820004 121120298 123021028 012121144 030521014 030521042 032221350 052421016 051522030 111021103 SX7250421RF / 00810047641667 Lot Numbers: 110821050 120221072 120820005 121120299 122921115 123021029 123021050 012121145 012222122 012622164 021021322 030521013 030521043 030821227 032221351 042221029 050422033 050422058 052421017 011322047 012822619 050224017 SX7250425RF / 00810047641674 Lot Numbers: 120221073 120820006 121120300 121321137 121421005 121421012 121421021 121621176 123021049 123021600 012121146 012622165 012622166 022622374 022622376 030521012 030521044 030521600 032221352 042221028 042221181 050422007 050422008 050422009 050422010 052421018 060421001 092021067 081721022 051522031 071422060 071422061 072822038 050623075 051423019 061023127 062323226 050224018 111021106 SX7250429RF / 00810047641681 Lot Numbers: 120820008 121120301 122921116 012121147 030521011 030521045 032221353 012822621 050224019 111021107 SX7250621RF / 00810047641698 Lot Numbers: 120820009 121120302 121120304 122921117 012121148 012822297 030521010 030521046 032221354 042221027 042221182 052421019 120221038 012822501 050623076 061023128 111021108 111021109 SX7250625RF / 00810047641704 Lot Numbers: 111121036 120221074 120820010 121120303 121120305 121621177 122921100 123021048 012121149 012822298 013022031 022622379 022622380 030521009 030521047 032221355 042221026 042221183 050721020 052021012 052421020 052421021 070323020 071621016 012822622 012822502 042823047 050623077 051423020 061823143 050224020 050524011 SX7250629RF / 00810047641711 Lot Numbers: 120820011 121120306 121421022 122921101 012121150 030521008 030521048 032221356 052421022 012822503 111021114 111621104 SX7300421RF / 00810047641728 Lot Numbers: 110821049 120820012 121120307 012121151 021021326 030521007 030521049 032221357 042221025 011322048 041924366 SX7300425RF / 00810047641735 Lot Numbers: 120820013 121120308 122921102 012121152 012822299 013022011 020222058 021021327 022622383 022622384 030521006 030521050 040424042 042221024 042221184 042823006 051423008 052421023 070323019 012822504 042823048 050623078 051423021 062323227 041924367 042024080 050224021 050524012 111021117 SX7300429RF / 00810047641742 Lot Numbers: 120820015 012121153 021021328 030521005 030521051 032221358 041221396 050324054 050422011 012822625 111021118 111621108 SX7300621RF / 00810047641759 Lot Numbers: 120820016 012121154 013022033 030521004 030521052 032221359 041221397 042221023 042221185 050422057 052421024 012822505 111621109 SX7300625RF / 00810047641766 Lot Numbers: 120820017 121621180 012121155 012822300 021021329 030521003 030521053 041221398 042221022 042221186 052021013 052421025 052421026 070323018 042823049 050623079 051423022 061823144 050224022 111021121 SX7300629RF / 00810047641773 Lot Numbers: 120820018 012121156 012822301 030521002 032221360 041221399 052421027 061421122 070121024 042823050 111021123 111621112 SX7350421RF / 00810047641780 Lot Numbers: 120820019 012121157 030521001 030521055 032221361 041221400 042221187 042221254 052421028 012822507 050224023 111021124 111621113 SX7350421RF / 00810047641728 Lot Number: 011322049 SX7350425RF / 00810047641797 Lot Numbers: 120820020 123021031 123021047 012121158 020222060 021021330 030521056 041221401 042221253 050324053 050324065 052421029 120221039 042823051 062323228 050224024 050524013 111021125 111621114 SX7350429RF / 00810047641803 Lot Numbers: 120820021 123021032 030521034 030821052 032221362 041221402 050324052 052421030 012822509 111021127 SX7350621RF / 00810047641810 Lot Numbers: 120820022 012121160 013022036 030821051 030821116 032221363 041221403 052421031 012822510 111621117 SX7350625RF / 00810047641827 Lot Numbers: 120820023 123021046 012121161 012822303 021021331 030821050 030821117 041221404 050324051 050721022 052421032 051721257 012822627 012822511 111621118 SX7350629RF / 00810047641834 Lot Numbers: 120820024 012121162 030821049 030821118 032221364 041221405 111021131 111621120 SX7400421RF / 00810047641841 Lot Numbers: 120820025 012121163 012822028 022622393 030821119 032221365 041221406 042221252 052021014 012822513 SX7400425RF / 00810047641858 Lot Numbers: 120221075 120820026 012121164 012222123 013022017 021021332 030821242 041221407 042221188 042221251 050324050 050422034 052421034 120221040 012822514 042823052 050623080 051423023 050224025 050524014 111021134 SX7400429RF / 00810047641865 Lot Numbers: 110421038 120820027 012121165 022622397 030821046 032221366 041221408 012822628 111021135 SX7400621RF / 00810047641872 Lot Numbers: 120820028 012121166 012822304 013022039 030821045 030821122 032221367 041221409 012822515 111021136 SX7400625RF / 00810047641889 Lot Numbers: 120820029 121421006 123021033 012121167 012822305 021021333 022622399 041221410 050422012 050721023 052421035 051721263 110221059 012822516 012822629 111021137 111621126 SX7400629RF / 00810047641896 Lot Numbers: 110421039 120820030 012121168 012822025 030821043 030821124 032221368 041221411 012822517 111021139 111621127 SX7450421RF / 00810047641902 Lot Numbers: 120820031 012121169 012822024 030821042 030821125 032221369 041221412 012822518 SX7450425RF / 00810047641919 Lot Numbers: 120221076 120820032 123021034 123021045 012121170 012822023 030821041 030821126 041221413 051221004 070323016 080921053 012822519 111621129 SX7450429RF / 00810047641926 Lot Numbers: 120820033 012121171 012822022 030821040 030821127 032221370 041221414 051721267 111021142 SX7450621RF / 00810047641933 Lot Numbers: 120820034 012121143 012822021 013022042 030521024 030821039 032221371 041221415 051721268 111621131 SX7450625RF / 00810047641940 Lot Numbers: 120820035 123021035 123021044 012121142 012822020 012822306 022622404 030521025 030821038 032221372 041221416 050422081 051721269 012822630 111021144 111621132 SX7450629RF / 00810047641957 Lot Numbers: 120820036 012121141 030521026 030821037 032221373 041221417 111021145 111621133 EdgeGlidePath REF: SEGP0221 / 00819514028710 Lot Numbers: 121120230 021121229 021821059 030521194 030821240 041621009 042021273 042221261 042221295 052121213 120720383 121120230 072223020 041924329 111021001 SEGP0225 / 00819514028727 Lot Numbers: 120720384 121120231 012822064 021821060 030521193 040524010 041621010 042021274 042221204 042221260 042221296 042821261 052121212 070323002 080523090 092021064 032521252 041421055 012822421 051522016 071422041 061823127 081123184 041924335 111021002 SEGP0231 / 00819514028703 Lot Numbers: 120720388 121120232 021121212 021821061 030521192 041621012 042021283 042221259 012822577 051423009 111021003 EdgeOne Fire REF: SEOFAST21 / 00810047642176 Lot Numbers: 121120283 123021058 020222094 022622321 022622322 030521229 030821061 041621071 012121022 033021394 012822578 102221004 111021600 111621604 SEOFAST25 / 00810047642183 Lot Numbers: 110421002 110421600 110821602 120820146 121120284 121321138 121421004 121421017 121521014 012622155 012822290 030521228 030821062 031021170 032221336 032521271 040524007 040921065 041621072 042021271 042221039 050721018 080921051 092021062 012822238 032722073 040921062 041421091 041421006 012822579 102221005 111621005 SEOFAST31 / 00810047642190 Lot Numbers: 110421025 121120285 121120286 121521009 123021053 012522023 012622157 030521227 030821063 041621073 051221003 052021007 052121209 080921052 012121024 033021395 040921063 041421007 012822580 102221006 111021006 121521025 111621603 SEOFLG21 / 00810047642145 Lot Numbers: 110421020 110421021 110520310 120720371 121521005 121521006 123021063 012522038 012822057 013022057 022322064 030122072 030521199 032424023 041224043 041621068 050324074 051624002 052121206 081021005 012822232 012121019 020321178 122021083 32924061 32924052 012822581 102221007 111021007 121521026 111621611 SEOFLG25 / 00810047642152 Lot Numbers: 110520311 110821068 110821070 121321131 121321149 121421011 121521012 121521013 123021064 011322193 012222126 012222127 012522039 030521198 041224042 041621069 042221269 050324075 050422019 050721006 051024001 052121205 070323003 070921032 080523091 080921049 080921068 081021006 012822234 012822235 041421003 041421089 110221058 120521099 122021084 011322045 121521024 012822582 102221008 111021008 121521027 SEOFLG31 / 00810047642169 Lot Numbers: 110520312 120720373 123021040 030521197 041621070 042221268 050422020 052121204 012121021 020321180 033021393 041421004 012822422 111021009 121521028 111621610 SEOFMED21 / 00810047642114 Lot Numbers: 110520307 120720362 120720363 120720364 121421028 123021061 012522036 012822050 012822324 013022060 020222108 022622285 022622286 022622287 030122071 030521105 030521202 041224044 041224059 041621065 051423005 052121203 070323007 070323035 080523069 081021004 012822227 012121016 020321175 111021010 121521029 SEOFMED25 / 00810047642121 Lot Numbers: 110421019 110520308 120720365 120720366 120720367 120720368 121321132 121321148 121421010 121421015 121421026 121521004 123021062 011322191 012222125 012522037 012822051 012822052 012822053 012822054 012822055 022322062 030521106 030521201 032521273 040424035 041621066 042221271 050324041 050324072 050422018 050422035 050721001 050721005 051024002 070323005 070323006 080523092 081021009 032722071 110221057 012121017 020321176 101421018 120221036 122021082 012822583 111021011 121521030 111621608 SEOFMED31 / 00810047642138 Lot Numbers: 110520309 120720369 030521200 041621067 042221270 051421044 052121201 070323004 070323036 012121018 020321177 041421002 041421088 012822584 111021012 121521031 111621613 111621614 SEOFPRI21 / 00810047642084 Lot Numbers: 110421023 110520304 110821066 120720351 120720352 121321135 121321145 121421008 121421014 121421024 121521007 121521011 010622032 011322189 012822001 012822003 012822321 013022063 022322051 022622227 022622233 030521163 030521253 040524008 040921068 041621062 050324046 050324069 050422017 070323014 071921019 071921020 071921021 071921022 081021007 012822191 032722063 012121010 020321163 071621013 081721019 120521096 120221033 011322042 111521602 012822586 012822585 050623060 051423010 061823128 080523020 081123185 072223022 050524002 111021013 111021602 111621607 SEOFPRI25 / 00810047642091 Lot Numbers: 101821070 110421005 110421018 110421601 110520305 110821603 110821604 120720353 120720354 120720355 120720356 120720357 120720358 121321133 121321134 121321146 121321147 121421009 121421025 121521003 121521016 122021020 122921111 123021015 123021039 123021060 010622031 012522027 012522028 012522031 012522032 012522034 012622050 012622051 012622052 012622053 012622054 012622056 012822030 012822031 012822032 012822033 012822322 013022065 013022220 020222075 020422004 021121228 022322053 022322055 022322057 022322058 022322059 030521103 030521204 030821237 040921069 040921069 041621063 050324044 050324045 050324070 050721004 052421107 061823012 061823087 062323128 071321030 071921023 071921024 071921025 071921026 072923055 072923056 072923057 080523053 080523054 080523055 080523056 080523057 080523058 080523059 080523060 080523061 080523062 080523063 080523064 080523065 080523066 080523067 080523068 080523093 081021001 081021002 081021008 081123009 081123010 042323052 042323054 042323055 042323056 042323057 042323058 042323059 042323060 012121013 012121014 012121011 012121012 020321165 020321169 071621014 081721020 101421017 110221056 120521098 120221034 120521097 111521604 072223021 102221014 121521032 111621606 SEOFPRI31 / 00810047642107 Lot Numbers: 110520306 120720359 120720360 120720361 122921112 012522035 012822049 012822323 013022066 030521104 030521203 040524009 041423152 041423153 041423166 041621064 041623023 050324043 051024004 051423003 051423004 052121198 070323008 072923058 042323061 012121015 020321174 120221035 011322044 012822587 102221016 111021015 121521033 111621605 SEOFSM21 / 00810047642053 Lot Numbers: 110520301 120720344 120720345 122921109 123021038 123021042 010622033 012522024 012822008 012822318 020522233 030122066 030521207 030821236 041224048 041621059 042221275 050324049 052121197 070323015 070323033 071921018 080523050 012121007 020321159 033021391 041421083 120221032 012822588 111021016 121521034 111621612 SEOFSM25 / 00810047642060 Lot Numbers: 110421024 110520302 110821605 112221600 120720346 120720347 121321136 121321143 121321144 121421007 121421013 121521008 122021019 122921110 123021059 011322188 011322200 012222124 012522025 012822319 021121227 030221390 030521206 032521272 041224047 041224058 041621060 042221197 042221274 050324048 050324067 050422016 050422063 050721003 080523051 080523052 081123094 081123095 081123096 081123097 012822181 012822184 012822186 033021392 041421084 101421016 110221055 121521022 011322041 111521603 012822589 051423011 041924338 102221018 111021017 111621017 SEOFSM31 / 00810047642077 Lot Numbers: 110520303 120720349 120720350 012822320 013022069 030521205 032221378 041224046 041621061 052121195 012822187 012121009 041421001 120521095 012822590 111021018 121521035 111621601 EdgeOne Fire GlidePath REF: SEOFGP21 / 00819514028680 Lot Numbers: 110421003 110821063 120820150 121521010 121521015 032221337 041224035 041423165 041621074 050324058 050324062 051024012 051624001 052121208 052421006 SEOFGP25 / 00819514028697 Lot Numbers: 110421027 120820152 121421018 121521021 012522009 012822291 030521225 030821244 032221338 041224038 041621075 050324063 051024008 070323029 072923072 072923077 081123088 092021065 SEOFGP31 / 00819514028673 Lot Numbers: 120820154 030521224 030821243 041621076 043021600 050324057 052021008 052121207 041124172 EdgeTaper REF: SET21MM / 00810047640004 Lot Numbers: 120820137 121120280 122921121 012522158 020522229 030521232 030821058 030821247 042021286 122021080 012822591 111021047 SET25MM / 00810047640011 Lot Numbers: 110421035 110821060 120820140 121120281 121421003 123021075 012522159 012522160 012522161 012522162 030521231 030821059 030821246 031021171 041421082 110221054 012822592 082622016 042823036 050623064 051423012 080523023 081123186 050224006 111021048 SET31MM / 00810047640028 Lot Numbers: 120820144 121120282 123021076 020222093 021821057 030521230 030821060 042221041 042221230 012822178 012822593 111021049 SETF121 / 00819514029854 Lot Numbers: 110821055 120820095 121120258 030821020 042221006 042821273 052021003 060421019 012822149 081721016 111021050 012822594 082622017 061823129 080523024 SETF125 / 00819514029861 Lot Numbers: 110421030 120820096 120820097 121120259 012522111 030812019 042221005 042221216 042821274 060421020 071921028 012822150 012822151 012822152 041421072 071621012 101421015 120221029 122021079 071422045 082622019 050623065 061823130 080523025 081123188 050524005 111021052 SETF131 / 00819514029878 Lot Numbers: 121120260 050324059 051024010 120820099 030821018 032521260 041421073 012822598 051522020 SETF221 / 00819514029885 Lot Numbers: 121120261 042821275 060421021 121820100 030821017 042221004 042221217 012822153 041221394 041421074 051522021 042823037 061823131 080523027 SETF225 / 00819514029892 Lot Numbers: 121120262 042821276 060421022 081021012 123021072 012822079 020522341 121820101 121820102 020321125 030821016 030821108 110421031 012822154 030221305 031521335 041421075 120521093 012822549 051522022 060622005 080523028 081123190 SETF231 / 00819514029908 Lot Numbers: 121120263 042821277 120820104 030521186 030821109 012822156 081721017 012822551 072223026 SETF321 / 00819514029915 Lot Numbers: 121120264 120820105 030521185 030821014 030821015 042221003 012822553 080523030 050524006 SETF325 / 00819514029922 Lot Numbers: 121120265 042821278 060421023 122921120 120820106 120820107 030821013 030821111 110421032 012822158 032521261 041421076 012822555 060622006 062323213 081123192 111021059 SETF331 / 00819514029939 Lot Numbers: 121120266 120820109 030821012 030821112 042221002 012822159 081721018 012822556 SETF421 / 00819514029946 Lot Numbers: 121120267 120820110 030821011 030821113 042221219 120221030 111021061 SETF425 / 00819514029953 Lot Numbers: 121120268 123021073 120820111 120820112 120820113 020321123 030821010 030821114 042221001 042221220 110421033 080921069 012822559 SETF431 / 00819514029960 Lot Numbers: 121120269 120820114 030821009 030821070 012822161 111021063 SETF521 / 00819514029977 Lot Numbers: 121120270 120820115 030521277 030821008 042221221 012822162 081123195 111021064 SETF525 / 00819514029984 Lot Numbers: 121120271 123021074 120820116 030521278 030821007 042221222 042221283 052021004 110421034 080921070 081122024 111021065 SETF531 / 00819514029991 Lot Numbers: 121120272 120820117 030521279 030821006 052021005 012822164 111021067 SETS121 / 00819514029793 Lot Numbers: 121120273 042821279 060421024 071921029 020522340 022322047 120820118 030521280 030821005 042221223 042221282 041621052 012822165 041421077 012822567 051522024 071422051 061823133 080523034 SETS125 / 00819514029809 Lot Numbers: 121120274 042821280 071921030 110821056 012522133 012522134 051024011 120820119 120820120 030521281 030821004 042221224 042221281 041621053 030221306 031521336 032521262 041421078 120521094 012822568 051522025 060622010 062323216 081123197 SETS131 / 00819514029816 Lot Numbers: 121120275 042821281 071921031 110821057 120820123 030521282 030821003 042221225 123021013 041621054 120221031 SETS221 / 00819514029823 Lot Numbers: 121120276 060421027 012522141 120820124 030521283 030821002 042221226 042221280 041621055 041421079 012822572 050623070 081123199 SETS225 / 00819514029830 Lot Numbers: 121120277 042821282 110821058 012522147 012522148 120820126 042221227 042221279 041621056 012822170 030221307 031521337 032521263 041421080 012822573 031122064 051522026 082622028 061823136 080523035 111021074 SETS231 / 00819514029847 Lot Numbers: 121120278 110821059 112221078 012522150 021822062 120820130 041621057 012822171 032521264 012822575 SETSX19 / 00819514029786 Lot Numbers: 121120279 042821284 071921032 081021013 012522153 012522154 012522155 012522156 020522270 050324061 120820131 030521233 042221228 042221277 042221278 012622148 032221335 041621058 012822172 012822173 030221308 041221395 041421081 110221053 011322040 051522028 060622013 071422054 072822031 042823042 050623072 051423015 062323218 072223029 080523036 081123201 050224010 111021076 EdgeTaper Platinum REF: SETF121HT / 00810047640103 Lot Numbers: 012522079 121120233 042821268 110821053 123021067 012622068 050422037 120720389 120720390 120720391 030521191 042221258 010622029 010622030 012222128 012222129 052121192 013022087 041621013 021121213 121621159 030221295 031521332 041421056 032521254 081721007 110221046 120221013 012822595 071422044 082422067 062323211 081123187 111021051 SETF125HT / 00810047640110 Lot Numbers: 121120234 081021010 122921107 020222068 020522234 022322037 022622032 080523089 051024021 120720392 120720393 120720395 120720396 030521190 030521250 042221205 042221257 121421027 010622027 010622028 012222130 012222132 032221379 050721007 013022071 041621014 041621015 041621016 021121214 121621160 012822328 030221296 032521253 041221386 101421009 120221014 120521087 122021071 011322032 012822597 060622004 071422046 072822039 081122021 082622020 050623066 081123189 080523026 111021053 SETF131HT / 00810047640127 Lot Numbers: 121120235 042821270 060421014 081823369 120720397 030521189 030521251 032521274 050721008 052121190 041621017 121621161 012822330 030221297 120221015 122021072 072223025 111021054 SETF221HT / 00810047640134 Lot Numbers: 121120236 042821271 123021068 020222105 022322038 022622041 050422045 050422046 120720398 120720399 030521188 042221256 121321150 122021021 010622025 010622026 052121189 013022089 041621018 021121215 121621162 012822331 032521255 041421060 081721008 110221048 120221016 122021073 012822601 071422047 082622021 111021055 SETF225HT / 00810047640141 Lot Numbers: 121120237 042821272 060421016 081021011 122921108 123021069 020222103 020222104 020522235 022622046 022622047 080523088 051024020 120720400 120720401 120720402 120720403 120720404 120720427 120720428 120720429 120720425 030521187 042221206 010622022 010622024 011322202 012222138 012222139 012222140 012222141 013022225 032221380 032521275 050721009 052121188 123021016 120221145 012522003 013022072 041621020 041621021 041621019 021121216 121621163 012822334 030221298 032521256 041221387 081721009 101421010 110221049 120221017 120521088 122021074 011322033 012822550 071422048 072822040 081122022 042823038 062323212 080523029 081123191 111021056 111021057 SETF231HT / 00810047640158 Lot Numbers: 121120238 122921118 020522236 022322039 042122001 080523087 120720405 120720430 052121187 050721010 041621022 121621164 121621165 041221388 071621008 120221018 122021075 SETF321HT / 00810047640165 Lot Numbers: 121120239 110821054 012222137 020222102 120720406 120720408 ,120720407 120720431 120720433 012622089 052121186 041621023 012822336 120221084 121621166 081721010 111021058 SETF325HT / 00810047640172 Lot Numbers: 121120240 122921119 123021070 020222100 022622068 022622070 022622071 080523086 120720409 120720410 120720411 120720412 120720413 120720434 030521150 042221207 050721011 013022073 041621024 041621025 041621026 021121217 121621167 012822337 012822338 030221299 031521333 032521257 041221389 101421011 110221050 120221019 122021076 011322034 012822484 060622007 082622023 071422049 081122023 042823039 051423013 080523031 081123193 SETF331HT / 00810047640189 Lot Numbers: 121120241 112221072 022322040 050422054 120720414 120720439 030521155 052021020 123021041 052121184 041621027 120221085 121621168 121621169 012822557 072223027 111621053 SETF421HT / 00810047640196 Lot Numbers: 121120242 012222135 050422041 120720415 030521154 010622021 052121183 041621028 120221086 121621170 081823379 111621054 SETF425HT / 00810047640202 Lot Numbers: 121120243 123021071 012622094 020522238 120720416 120720417 030521153 012622097 052121182 123021017 013022074 041621030 041621029 121621171 041221390 041421064 012822560 082622024 081123194 111021062 SETF431HT / 00810047640219 Lot Numbers: 121120244 120720420 030521152 052121181 041621031 120221087 121621172 032521258 012822561 SETF521HT / 00810047640226 Lot Numbers: 121120245 120720421 120720446 030521151 052121180 041621032 120221088 121621173 012822485 111621057 SETF525HT / 00810047640233 Lot Numbers: 042823004 121120246 020222098 022322042 012222134 020222099 120720448 011322194 011322203 052121179 013022075 041621033 041621034 012822345 012822346 081721011 012822562 062323214 111021066 SETF531HT / 00810047640240 Lot Numbers: 121120247 042021275 120820054 030821033 030821071 042221021 042221210 052121178 041621035 120221070 121621145 121621146 012822265 120221020 SETP21MM / 00810047640257 Lot Numbers: 121120255 110821051 122921106 020222047 012822076 020522343 022622118 120820080 030821098 030821025 122021016 011322196 011322197 121421001 123021056 013022083 041621047 021121208 031521396 121621154 012822144 012822145 011322038 012822564 050623067 111621059 SETP25MM / 00810047640264 Lot Numbers: 020522194 121120256 042221294 042021279 063021025 012522073 012522074 012522076 012622139 012622140 012622141 012622143 012622145 012822077 012822078 020222087 012622138 012622142 022622137 080523096 080523097 080523098 051024025 120820084 030521184 030821250 030221388 030821099 030821101 030821102 030821100 040921064 042221008 110421001 110821069 110821073 122021017 121321139 121321140 121421002 121421016 010622034 010622035 011322198 011322199 013022213 013022214 021821055 032221334 032521270 050721016 123021011 120221143 012522011 041621048 041621050 041621049 021121209 110421036 120221071 121621155 012822147 012822146 030221304 041421071 071621011 120221028 120521092 011322039 012822565 060622008 060622009 071422050 061823132 062323215 072223028 080523033 081123196 050224007 111021069 111621060 SETP31MM / 00810047640271 Lot Numbers: 042823003 121120257 110821052 020222091 050324060 120820094 030821021 030821022 030821023 030821024 030821103 042221007 021821056 030221389 050721017 123021012 012522010 041621051 110421029 031521397 012822566 111621061 SETS121HT / 00810047640042 Lot Numbers: 121120248 042821262 060421002 020222045 120820055 120820058 030821032 042221020 052021001 012622104 052121177 013022096 041621036 021121218 121621147 030221300 041221391 120221021 012822486 082622025 050623068 061823134 111021071 SETS125HT / 00810047640059 Lot Numbers: 012522047 121120249 042221293 042821263 122921103 020522345 012622112 030122027 050422022 051522021 072923071 051024022 120820062 120820059 030821031 030821074 030821075 030821076 042221018 042221019 042221211 012222103 012222104 012622105 012622108 012622109 012622110 012622111 013022208 032521267 050721014 120221139 123021007 012522015 013022077 013022097 041621037 041621038 012822269 121621148 012822267 012822268 012822130 030221301 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FEI Number 3008857765
Recalling Firm/
Manufacturer		 US Endodontics, LLC
2809 W Walnut St
Johnson City TN 37604-6333
For Additional Information ContactLacey Vinson
+1-423-2830047
Manufacturer Reason
for Recall		Due to devices being irradiated above the established specification which my result in package integrity issues.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 01/02/2025, the firm email an "URGENT MEDICAL DEVICE CORRECTION NOTICE" to customer informing them that sterility of the product may have been compromised due to over irradiation during routine sterilization processing. Customers are instructed to: 1. Confirm if they have any of the impacted Lots. 2. if they have any of the impacted Lots, they are to evaluate the package seal for any potential seal breaches or degradation of the packaging material, which may indicate a lack of sterility in the product. 3. If there are any concerns with the package seal integrity, treat the device as non-sterile product and follow the sterilization instructions in DES-DFU-21001 Rev. F page 6 which provides the following instructions: . Files are single use only and not meant for reprocessing. . Autoclaving should be performed immediately before use. . Place the instruments unwrapped in an autoclave tray. . Use fresh distilled or deionized water. . Insert in a steam gravity cycle autoclave at 134C-137C with a max temp of 140C for a minimum 3 minutes. . Aseptic transport to the point of use should follow autoclaving. . Storage of the sterilized device is not recommended. For Questions contact US Endodontics Customer Care Service at +1 423-722-5626.
Quantity in CommerceTotal devices=789,729 (47,508 devices (U.S.) and 742,221 device (O.U.S.))
DistributionWorldwide - US Nationwide distribution in the state of GA and the countries of Australia, Canada, the European Union (specifically France, Germany, Italy, Poland, and Spain), and the UK.
Total Product Life CycleTPLC 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.
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