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U.S. Department of Health and Human Services

Class 2 Device Recall AcuTwist Acutrak Compression Screws

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  Class 2 Device Recall AcuTwist Acutrak Compression Screws see related information
Date Initiated by Firm November 29, 2022
Date Posted December 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-0770-2023
Recall Event ID 90996
510(K)Number K221333  
Product Classification Screw, fixation, bone - Product Code HWC
Product Dual-Trak Clavicle Screws
Part Number/Part Description:
40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw
40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw
40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw
40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw
40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw
40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw
40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw
40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw
40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw
40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw
40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw
40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw
40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw
40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw
40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw
40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw
40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw
40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw
40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw
Code Information Dual-Trak Clavicle Screws: Batch Number/Part Number/Part Description/UDI Code: 237352 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-237352000000 241396 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-241396000000 251499 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-251499000000 273721 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-273721000000 295968 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-295968000000 305419 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-305419000000 320123 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320123000000 320365 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320365000000 320998 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-320998000000 353959 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-353959000000 360734 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-360734000000 361151 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-361151000000 376436 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-376436000000 377113 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-377113000000 379009 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379009000000 379939 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379939000000 379920 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-379920000000 410141 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-410141170413 410142 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-410142170413 423108 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-423108171009 423212 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-423212171009 441951 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-441951180523 442003 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-442003180524 477282 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-477282190808 477323 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-477323190809 500931 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-500931200601 501581 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-501581200610 525006 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525006210405 525005 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525005210405 525007 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525007210405 525102 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525102210406 525505 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-525505210412 556268 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556268220222 556269 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556269220222 556358 40-0136 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028410-556358220223 293645 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-293645000000200228 383916 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-383916160608230608 421116 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-421116170906240905 534467 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-534467210709280708 565996 40-0136-S 3.0mm x 80mm Dual-Trak Clavicle Screw 10806378028427-565996220615290614 241398 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-241398000000 251500 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-251500000000 273722 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-273722000000 295969 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-295969000000 305610 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-305610000000 320392 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-320392000000 320999 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-320999000000 354105 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-354105000000 360645 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-360645000000 360733 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-360733000000 376553 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-376553000000 380465 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-380465000000 380466 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-380466000000 410223 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-410223170413 410222 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-410222170413 425329 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-425329171030 441811 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-441811180522 441950 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-441950180522 477378 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-477378190812 477519 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-477519190813 501531 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-501531200609 525199 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-525199210407 525200 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-525200210407 555633 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555633220215 555695 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555695220216 555694 40-0137 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028434-555694220216 293646 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-293646000000200228 422954 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-422954171004241003 477838 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-477838190816260815 515467 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-515467201210271210 534468 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-534468210709280708 570282 40-0137-S 3.0mm x 90mm Dual-Trak Clavicle Screw 10806378028441-570282220804290803 237369 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-237369000000 241399 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-241399000000 251501 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-251501000000 295970 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-295970000000 305644 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-305644000000 320393 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-320393000000 361063 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-361063000000 376681 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-376681000000 377214 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-377214000000 380638 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-380638000000 381141 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-381141170717 424465 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-424465171019 424175 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-424175171019 477520 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-477520190813 500956 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-500956200602 525287 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525287210408 525201 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525201210407 525288 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-525288210408 556907 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556907220302 556774 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556774220228 557543 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-557543220310 556608 40-0138 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028458-556608000000 293647 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-293647000000200228 378213 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-378213160322230322 415996 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-415996170627240626 486375 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-486375191203261202 560151 40-0138-S 3.0mm x 100mm Dual-Trak Clavicle Screw 10806378028465-560151220403290402 241400 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-241400000000 251502 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-251502000000 305645 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-305645000000 320950 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320950000000 320903 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320903000000 377330 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-377330000000 320950A 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-320950A170720 423259 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-423259171013 423258 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-423258171012 525104 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-525104210406 525103 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-525103210406 554545 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554545220203 554669 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554669220204 554933 40-0139 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028472-554933220207 293663 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-293663000000200228 402890 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-402890170113240113 469205 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-469205190423260422 534470 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-534470210709280708 570283 40-0139-S 3.0mm x 110mm Dual-Trak Clavicle Screw 10806378028489-570283220804290803 237368 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-237368000000 241407 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-241407000000 251503 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-251503000000 320970 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-320970000000 320970A 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-320970A170630 423354 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-423354220103 423579 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-423579220103 555104 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555104220208 555184 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555184220209 555183 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-555183220209 557309 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-557309220308 557310 40-0140 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028496-557310220308 293664 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-293664000000200228 400322 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-400322161212231212 469203 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-469203190423260422 565999 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-565999220615290614 570284 40-0140-S 3.0mm x 120mm Dual-Trak Clavicle Screw 10806378028502-570284220804290803 237370 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-237370000000 241408 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-241408000000 251504 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-251504000000 305469 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-305469000000 361064 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-361064000000 376799 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-376799000000 380044 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-380044170531 380768 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-380768170531 477625 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-477625190814 501582 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-501582200610 555550 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-555550220214 555575 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-555575220214 555635 40-0143 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028519-555635220215 293665 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028526-293665000000200228 293665A 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028526-293665A171003241002 469204 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028526-469204190423260422 565998 40-0143-S 3.8mm x 80mm Dual-Trak Clavicle Screw 10806378028526-565998220615290614 241409 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-241409000000 251505 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-251505000000 305697 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-305697000000 320832 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-320832000000 321000 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-321000170616 361065 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-361065000000 379515 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-379515000000 380368 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-380368170616 424468 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-424468171019 477626 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-477626190814 501493 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-501493200609 555878 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-555878220217 555877 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-555877220217 557544 40-0144 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028533-557544220310 293666 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028540-293666000000200228 424385 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028540-424385171018241017 469983 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028540-469983190503260502 566000 40-0144-S 3.8mm x 90mm Dual-Trak Clavicle Screw 10806378028540-566000220615290614 237371 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-237371000000 241410 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-241410000000 251506 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-251506000000 320969 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-320969000000 376800 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-376800000000 379875 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-379875000000 380969 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-380969170605 379875A 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-379875A170605 425039 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-425039171025 477695 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-477695190815 525289 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-525289210408 525290 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-525290210408 556160 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-556160220221 556161 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-556161220221 556162 40-0145 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028557-556162220221 293667 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028564-293667000000200228 421117 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028564-421117170906240905 486376 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028564-486376191203261202 560152 40-0145-S 3.8mm x 100mm Dual-Trak Clavicle Screw 10806378028564-560152220403290402 241411 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-241411000000 251507 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-251507000000 376955 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-376955000000 410385 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-410385170418 425114 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-425114171030 442004 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-442004180524 500984 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-500984200602 501044 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-501044200603 555307 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-555307220210 555416 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-555416220211 557494 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-557494220309 555415 40-0146 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028571-555415220211 293668 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028588-293668000000200228 405572 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028588-405572170210240210 486377 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028588-486377191203261202 534471 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028588-534471210709280708 566001 40-0146-S 3.8mm x 110mm Dual-Trak Clavicle Screw 10806378028588-566001220615290614 237367 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-237367000000 241412 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-241412000000 251508 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-251508000000 304885 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-304885000000 377048 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-377048000000 381142 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-381142170623 425328 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-425328171025 501045 40-0147 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028595-501045200603 525506 40-0147 3.8mm x 120mm Dual-Trak 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40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028601-566002220615290614 570288 40-0147-S 3.8mm x 120mm Dual-Trak Clavicle Screw 10806378028601-570288220804290803
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9370
For Additional Information Contact Ellie Wood
214-738-1709
Manufacturer Reason
for Recall		 Distribution without Pre-Market Clearance
FDA Determined
Cause 2		 No Marketing Application
Action On 11/29-30/2022, Acumed LLC sent an "URGENT: MEDICAL DEVICE CORRECTION" Letter via USPS First Class with signature required to customers informing them that the Acutrak Headless Compression Screws and the Acutrak 2 Headless Compression Screw Systems were commercialized with a Pre-Market Clearance (510(k)). Customer are instructed to: Product within the scope of this correction does not need to be returned to Acumed. No actions are required as this is a compliance issue and not a patient safety issue. This notification is solely for your awareness. However, physicians are urged to notify Acumed of any adverse events or product safety issues. Additionally, adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. " Complete and submit the report Online " Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. Please complete the survey on Page 8 of this letter to indicate your receipt of this notice and to acknowledge you have read the content of this notice. Return the survey via email to RecallNotification@acumed.net. For questions - contact Acumed Business Services via email at BusinessServices@acumed.net or via phone at (888) 627-9957 Option 4 (US and Canada) or +001 (503) 627-9957 and choose Option 4 (outside of US and Canada)
Quantity in Commerce 7,498 units
Distribution Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, and WY. The countries of AE, AR, AU, BE, BR, CA, CH, CL, CN, CO, CR, DE, DK, EC, ES, FI, FR, GB, GT, HK, IE, IL, IT, JP, KR, KW, MX, MY, PA, PE, PR, PT, QA, SA, SE, SG, TH, TR, TW, and ZA.
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 = HWC and Original Applicant = Acumed LLC
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