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Class 2 Device Recall AcuTwist Acutrak Compression Screws |
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Date Initiated by Firm |
November 29, 2022 |
Date Posted |
December 23, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0769-2023 |
Recall Event ID |
90996 |
510(K)Number |
K221333
|
Product Classification |
Screw, fixation, bone - Product Code HWC
|
Product |
AcuTwist Acutrak Compression Screws Part Number/Part Description: AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw AI-0020 20mm AcuTwist¿ Acutrak Compression Screw AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw AI-0026 26mm AcuTwist¿ Acutrak Compression Screw AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw AI-0030 30mm AcuTwist¿ Acutrak Compression Screw AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw
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Code Information |
AcuTwist Acutrak Compression Device
Batch Number/Part Number/Part Description/UDI Code:
204010 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-204010000000160531
219050 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-219050000000170130
226652 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-226652000000170531
236972 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-236972000000171231
239079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-239079000000180131
260403 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-260403000000181231
265390 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-265390000000190228
270950 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-270950000000190331
273603 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-273603000000190731
278305 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-278305000000190930
358993 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358993000000220731
358079 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-358079150903220902
404026 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-404026170131240131
411204 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-411204170418240417
412910 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-412910170728240727
417672 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-417672170721240720
433231 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-433231180125250124
440500 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-440500180430250429
427818 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-427818180604250603
444129 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-444129181005251004
453386 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-453386181018251017
453539 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-453539181130251129
459459 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459459190114260113
459372 AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459372190319260318
459459A AI-0010-S 10mm AcuTwist¿ Acutrak Compression Screw 10806378054501-459459A190114260113
207543 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-207543000000160630
221773 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-221773000000170330
232103 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-232103000000170930
239090 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-239090000000180228
252663 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-252663000000180731
261805 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-261805000000190131
265385 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-265385000000190331
270951 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-270951000000190331
273604 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-273604000000190731
276600 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-276600000000190831
283677 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-283677000000191231
301351 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-301351000000200831
334669 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-334669000000211130
355218 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-355218150903220902
369265 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-369265160209230208
376423 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-376423160303230303
387265 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-387265161003231003
411897 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-411897170724240723
417673 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-417673170721240720
433232 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-433232180125250124
440501 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-440501180430250429
426684 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-426684180531250530
444012 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-444012180612250611
453387 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-453387181018251017
453540 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-453540181205251204
459460 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-459460190114260113
459373 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-459373190111260110
468010 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-468010190411260410
492287 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-492287200217270216
509415 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-509415200922270922
554972 AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-554972220207290206
554972A AI-0012-S 12mm AcuTwist¿ Acutrak Compression Screw 10806378054525-554972A220207290206
204011 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-204011000000160630
218592 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-218592000000161231
224771 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-224771000000170531
233064 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-233064000000171030
239085 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-239085000000180228
252664 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-252664000000180731
260404 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-260404000000181231
264920 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-264920000000190228
270952 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-270952000000190331
273605 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-273605000000190731
276601 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-276601000000190831
283678 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-283678000000191231
310758 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-310758000000201231
341293 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-341293000000220228
358994 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-358994000000220731
365605 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-365605151204221203
395810 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-395810161014231014
403328 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-403328170306240305
422718 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-422718180110250109
430350 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-430350171228241227
433234 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-433234180125250124
440502 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-440502180430250429
428302 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-428302180529250528
453388 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453388181018251017
453541 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453541181205251204
459461 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-459461190114260113
459374 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-459374190111260110
492288 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-492288200217270216
453541A AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-453541A181205251204
541180 AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-541180210907280906
541180A AI-0014-S 14mm AcuTwist¿ Acutrak Compression Screw 10806378054549-541180A210907280906
202127 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-202127000000160331
207544 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-207544000000160730
219051 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-219051000000170130
221774 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-221774000000170330
228560 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-228560000000170630
236973 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-236973000000171231
239086 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-239086000000180228
255718 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-255718000000180930
263764 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-263764130131190131
270953 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-270953000000190331
267149 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-267149000000190430
278306 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-278306130930190930
293298 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-293298000000200430
326969 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-326969000000210731
349764 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-349764000000220630
358995 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-358995000000220731
369262 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-369262160218230217
398310 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-398310170106240106
423537 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-423537180109250108
430351 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430351171227241226
433233 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-433233180125250124
440503 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-440503180430250429
453390 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-453390181018251017
453542 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-453542181130251129
430022 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430022171213241212
455496 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-455496181116251115
459375 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-459375190111260110
468011 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-468011190411260410
468011A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-468011A190411260410
430022A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-430022A171213241212
537368 AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-537368210806280805
537368A AI-0016-S 16mm AcuTwist¿ Acutrak Compression Screw 10806378054563-537368A210806280805
200695 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-200695000000160331
208829 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-208829000000160730
219175 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-219175000000170131
220153 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-220153000000170131
225031 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-225031000000170531
236002 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-236002000000171231
239089 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-239089000000180228
252665 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-252665000000180731
260405 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-260405000000181231
266045 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-266045000000190331
270954 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-270954000000190331
273606 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-273606000000190731
278307 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-278307000000190930
310759 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-310759000000201231
334670 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-334670000000211130
347466 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-347466000000220430
369263 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-369263160209230208
376424 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-376424160303230303
403329 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-403329170320240319
419309 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-419309171010241009
433235 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-433235180125250124
427819 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-427819180503250502
440504 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-440504180430250429
453391 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-453391181018251017
453416 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-453416181130251129
453415 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-453415181130251129
430023 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-430023181121251120
430023A AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-430023A181121251120
540349 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-540349210825280824
561463 AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-561463220418290417
540349A AI-0018-S 18mm AcuTwist¿ Acutrak Compression Screw 10806378054587-540349A210825280824
347469 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-347469000000
352881 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-352881000000
357435 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-357435000000
360895 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-360895000000
360896 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-360896000000
360983 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-360983000000
380559 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-380559170717
383861 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-383861000000
385662 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-385662000000
383861A AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-383861A170717
428469 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-428469180521
453559 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-453559000000
458446 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-458446181231
524631 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-524631210331
528174 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-528174210510
540216 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-540216210824
540215 AI-0020 20mm AcuTwist¿ Acutrak Compression Screw 10806378054594-540215210824
202198 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-202198000000160430
207545 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-207545000000160731
216619 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-216619000000161231
220154 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-220154000000170130
224772 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-224772000000170531
226654 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-226654000000170531
236305 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-236305000000171230
239087 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-239087000000180228
250209 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-250209000000180630
254691 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-254691000000180930
260406 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-260406000000181231
265386 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-265386000000190331
270955 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-270955000000190331
273607 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-273607000000190731
276602 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-276602000000190831
278308 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-278308000000190930
305622 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-305622000000201031
318862 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-318862000000210430
326031 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-326031000000210831
332358 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-332358000000211031
343091 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-343091000000220331
357447 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-357447000000220630
355062 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-355062150828220827
365606 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-365606151204221203
371676 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-371676160119230118
371680 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-371680160323230323
398311 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-398311170106240106
410449 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-410449170607240606
424155 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-424155180110250109
430352 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-430352171228241227
433236 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-433236180125250124
427820 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-427820180503250502
440505 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-440505180430250429
453392 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-453392181018251017
453543 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-453543181205251204
453544 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-453544181205251204
456005 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-456005190110260109
444130 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-444130181005251004
459376 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-459376190111260110
430024 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-430024171213241212
456005A AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-456005A190110260109
542922 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-542922211110281109
553927 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-553927220129290128
558561 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-558561220317290316
560526 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-560526220407290406
560526A AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-560526A220407290406
560526B AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-560526B220407290406
561464 AI-0020-S 20mm AcuTwist¿ Acutrak Compression Screw 10806378054600-561464220418290417
204013 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-204013000000160630
211408 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-211408000000160930
219176 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-219176000000170131
221775 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-221775000000170330
226660 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-226660000000170531
236003 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-236003000000171230
239091 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-239091000000180228
252667 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-252667000000180731
254692 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-254692000000180930
263577 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-263577000000190228
266046 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-266046000000190331
270956 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-270956000000190331
267150 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-267150000000190430
293299 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-293299000000200430
315879 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-315879000000210331
337999 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-337999000000220131
349765 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-349765000000220630
358996 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-358996000000220731
363002 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-363002151214221213
371678 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-371678160225230224
387262 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-387262161003231003
408710 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-408710170317240316
419310 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-419310171013241012
371678A AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-371678A171004241003
425008 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-425008171107241106
424156 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-424156180118250117
433237 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-433237180125250124
440506 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-440506180430250429
427964 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-427964180604250603
453394 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-453394181018251017
453545 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-453545190110260109
453546 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-453546190123260122
514061 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-514061201119271119
554973 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-554973220207290206
561003 AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-561003220413290412
554973A AI-0022-S 22mm AcuTwist¿ Acutrak Compression Screw 10806378054624-554973A220207290206
211409 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-211409000000160930
218426 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-218426000000161231
219177 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-219177000000161231
220155 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-220155000000170131
226661 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-226661000000170531
234909 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-234909000000171031
236306 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-236306000000171230
239080 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-239080000000180130
250210 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-250210000000180630
253343 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-253343000000180831
255719 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-255719000000180930
264921 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-264921000000190228
270957 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-270957000000190331
267151 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-267151000000190430
276603 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-276603000000190831
278309 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-278309000000190930
301352 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-301352000000200831
315880 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-315880000000210331
318863 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-318863000000210531
341295 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-341295000000220228
358997 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-358997000000220731
353311 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-353311150928220927
363003 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-363003151123221122
369261 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-369261160212230211
379200 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-379200160528230528
382492 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-382492160516230516
387263 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-387263161003231003
398312 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-398312170110240110
408712 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-408712170317240316
410450 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-410450170607240606
427550 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-427550171205241204
423538 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-423538180116250115
433238 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-433238180125250124
427816 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-427816180430250429
440507 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-440507180430250429
428303 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-428303171128250603
453395 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-453395181018251017
453547 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-453547181130251129
453548 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-453548181130251129
453549 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-453549181204251203
459377 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-459377190111260110
471402 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-471402190522260521
495516 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-495516200318270318
514062 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-514062201119271119
533287 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-533287210630280629
554974 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-554974220207290206
561004 AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-561004220413290412
554974A AI-0024-S 24mm AcuTwist¿ Acutrak Compression Screw 10806378054648-554974A220207290206
347470 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-347470000000
352882 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-352882000000
360897 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-360897000000
360898 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-360898000000
360984 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-360984000000
380560 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-380560000000
383862 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-383862000000
385663 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-385663000000
360898A AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-360898A170717
426682 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-426682180511
430694 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-430694171219
453847 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-453847181025
527545 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-527545210503
533900 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-533900210707
537102 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-537102210803
553030 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-553030220119
553029 AI-0026 26mm AcuTwist¿ Acutrak Compression Screw 10806378054655-553029220119
203701 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-203701000000160531
206877 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-206877000000160630
209573 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-209573000000160730
212145 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-212145000000160930
219178 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-219178000000170131
220156 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-220156000000170131
221456 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-221456000000170330
226662 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-226662000000170531
233544 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-233544000000171030
236004 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-236004000000171231
239088 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-239088000000180130
250211 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-250211000000180630
253341 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-253341000000180831
263578 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-263578000000190131
265387 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-265387000000190331
270958 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-270958000000190331
273608 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-273608000000190731
276604 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-276604000000190831
293300 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-293300000000200430
305628 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-305628000000200930
310760 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-310760000000201231
326032 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-326032140831210831
336740 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-336740000000220131
347467 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-347467000000220430
359121 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-359121150928220927
371677 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-371677160225230224
376426 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-376426160303230303
384039 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-384039160816230816
395811 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-395811161014231014
398313 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-398313170113240113
407672 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-407672170428240427
419868 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-419868170815240814
422412 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-422412171201241130
433239 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-433239180125250124
427822 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-427822180503250502
440508 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-440508180430250429
450230 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-450230180911250910
453551 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-453551190122260121
430026 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-430026171213241212
456532 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-456532181204251203
453550 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-453550190117260116
459378 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-459378190111260110
459379 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-459379190111260110
430026A AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-430026A171213241212
537148 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-537148210803280802
521461 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-521461210303280302
554975 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-554975220207290206
560527 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-560527220407290406
561465 AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-561465220418290417
554975A AI-0026-S 26mm AcuTwist¿ Acutrak Compression Screw 10806378054662-554975A220207290206
207546 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-207546000000160731
216726 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-216726000000161231
219350 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-219350000000170131
221457 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-221457000000170330
225032 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-225032000000170530
233546 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-233546000000171031
237466 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-237466000000171230
248000 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-248000000000180531
253342 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-253342000000180831
258537 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-258537000000181130
261807 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-261807000000190131
264922 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-264922000000190228
266047 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-266047000000190331
270959 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-270959000000190331
276605 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-276605000000190831
293301 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-293301000000200430
310761 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-310761000000201231
323680 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-323680000000210430
336732 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-336732211231211231
342858 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-342858000000220331
358998 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-358998000000220731
358080 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-358080150831220830
369260 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-369260160218230217
384040 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-384040160816230816
404025 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-404025170130240130
407503 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-407503170427240426
417674 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-417674170721240720
419311 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-419311171010241009
433240 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-433240180125250124
427817 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-427817180430250429
440509 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-440509180430250429
450234 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-450234180911250910
453552 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-453552181206251205
453553 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-453553190227260226
455497 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-455497181116251115
453554 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-453554190110260109
459462 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-459462190114260113
459380 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-459380190111260110
492289 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-492289200217270216
504701 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-504701200721270721
433240A AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-433240A180125250124
504701B AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-504701B200721270721
504701C AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-504701C200721270721
504701A AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-504701A200721270721
541177 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-541177210907280906
521462 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-521462210303280302
550865 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-550865211215281214
560528 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-560528220407290406
561005 AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-561005000000
550865A AI-0028-S 28mm AcuTwist¿ Acutrak Compression Screw 10806378054686-550865A211215281214
347471 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-347471000000
352883 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-352883000000
360899 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-360899000000
360900 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-360900000000
360985 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-360985000000
380561 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-380561000000
383863 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-383863000000
385664 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-385664000000
380561A AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-380561A170717
383863A AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-383863A170717
424032 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-424032180110
430695 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-430695171219
453420 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-453420181018
453560 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-453560181022
453561 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-453561181022
535721 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-535721210722
546945 AI-0030 30mm AcuTwist¿ Acutrak Compression Screw 10806378054693-546945211027
200696 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-200696000000160331
202571 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-202571000000160331
204014 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-204014000000160530
208830 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-208830000000160730
207547 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-207547000000160731
211279 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-211279000000160930
218280 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-218280000000170131
219179 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-219179000000170131
220157 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-220157000000170131
221458 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-221458000000170330
222722 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-222722000000170330
225033 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-225033000000170530
228561 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-228561000000170630
231970 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-231970000000170930
233547 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-233547000000171031
236974 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-236974000000171231
236005 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-236005000000171230
239092 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-239092000000180228
250212 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-250212000000180630
252668 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-252668000000180731
254693 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-254693000000180830
255720 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-255720000000180830
260407 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-260407000000181231
263579 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-263579000000190228
264923 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-264923000000190228
265389 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-265389000000190331
266048 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-266048000000190331
270960 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-270960000000190331
272210 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-272210000000190731
273609 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-273609000000190731
276606 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-276606000000190831
278310 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-278310000000190930
283679 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-283679000000191231
293302 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-293302000000200430
301353 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-301353000000200831
305629 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-305629000000201031
310762 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-310762000000201231
315881 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-315881000000210331
318864 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-318864000000210430
323681 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-323681000000210630
326033 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-326033000000210831
331751 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-331751000000210831
336738 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-336738000000220131
344083 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-344083000000220131
336744 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-336744000000220131
342859 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-342859000000220331
349766 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-349766000000220630
359123 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-359123150828220827
357434 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-357434150828220827
353312 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-353312151012221011
362027 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-362027151112221111
365607 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-365607151204221203
369259 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-369259160104230103
369258 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-369258160212230211
376427 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-376427160303230303
371679 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-371679160322230322
379201 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-379201160628230628
387264 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-387264161003231003
397029 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-397029170109240109
403330 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-403330170320240319
410451 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-410451170607240606
414901 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-414901170823240822
417005 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-417005171025241024
424157 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-424157180110250109
422413 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-422413180116250115
433241 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-433241180125250124
440510 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-440510180430250429
427959 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-427959180529250528
430028 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-430028171213250906
430029 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-430029171213250830
444131 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-444131181005251004
448366 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-448366180813250812
450235 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-450235180911250910
453418 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453418181127251126
452526 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-452526181206251205
453419 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453419181206251205
453556 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453556190123260122
453557 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453557190110260109
453558 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453558190110260109
456533 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-456533181204251203
453555 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453555190117260116
459381 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-459381190111260110
459383 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-459383190111260110
459382 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-459382190111260110
471403 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-471403190522260521
478950 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-478950190904260903
504702 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-504702200721270721
453419A AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453419A181206251205
507089 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-507089200824270824
514063 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-514063201119271119
453419B AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-453419B181206251205
524654 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-524654210331280330
524654A AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-524654A210331280330
541178 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-541178210907280906
533288 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-533288210630280629
521463 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-521463210303280302
554978 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-554978220207290206
554977 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-554977220207290206
554979 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-554979220207290206
554980 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-554980220207290206
560529 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-560529220407290406
561466 AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-561466220418290417
554980A AI-0030-S 30mm AcuTwist¿ Acutrak Compression Screw 10806378054709-554980A220207290206
|
Recalling Firm/ Manufacturer |
Acumed LLC 5885 NW Cornelius Pass Rd Hillsboro OR 97124-9370
|
For Additional Information Contact |
Ellie Wood 214-738-1709
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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 |
80,805 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
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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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510(K) Database |
510(K)s with Product Code = HWC and Original Applicant = Acumed LLC
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