Serial Numbers (US): 0355239 0355108 0355474 0354538 Serial Numbers (OUS): 0353919 0354845 0354849
Serial Numbers (US): 0353901 0354506 0354220 0355550 0355016 0350789 0354111 0354321 0352939 0353154 0353812 0354828 0354576 0354180 0355588 0355064 0353912 0351237 0351983 0354434 0353374 0351642 0352751 0355557 0353757 0353944 0354218 0353846 0353688 0355110 0352483 0345608 0353771 0353306 3054517 Serial Numbers (OUS): 0348705 0349592 0351522 0351616 0352700 0352750 0352827 0352840 0352999 0353210 0353225 0353263 0353420 0353514 0353515 0353577 0353714 0353791 0353822 0353918 0353921 0354163 0354208 0354284 0354292 0354439 0354507 0354509 0354605 0354771 0354773 0354792 0355178 0355188 0355202 0355227
Serial Numbers (US): 0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233
Serial Numbers (US): 0355146 0354541 0355265 0354782 0355485 0355303 0352821 0354413 0353756 0351007 0354577 0354250 0352676 0354571 0353838 0353285 0347734 0354520 0354841 0354148 0353307 0355478 0354830 0353427 0353729 0353683 0353887 0351415 0354255 0354219 0355807 0353995 0352944 0353305 0352331 Serial Numbers (OUS): 0347979 0349420 0351218 0351279 0351682 0351688 0351754 0351856 0352523 0352868 0352918 0353077 0353416 0353745 0353805 0353933 0354141 0354189 0354190 0354267 0354325 0354421 0354427 0354561 0354600 0354646 0354678 0354810 0354850 0355339 0355382 0355385
Serial Numbers: 0351869
Serial Numbers (US): 0354902, 0353696 Serial Numbers (OUS): 0349179 0352344 0352431 0352626 0353845 0353883 0353884 0354625 0355002 0355181
Serial Numbers (US): 0354697, 0353789, 0354533
Serial Numbers (US): 0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 0355561 0351297 0354882 0354343 0354746 0356253 0355288 0351033 0354279 0354994 0352643 0353878 0354579 0353642 0353612 0353882 0352852 0354051 0355244 0354198 0353638 0355030 0354485 0352979 0355292 0354752 0354992 0354915 0355643 0355534 0354406 0354834 0355706 0353989 0355877 0355175 0352628 0354616 0354740 0353368 0352993 0354481 0354768 0355262 0355375 0353458 0355484 0355865 0336962 0355154 0353183 0353452 0352902 0353126 0353139 0353927 0354087 0353911 0355624 0355128 0354275 0354378 0352822 0353001 0353300 0353327 0352113 0354712 0354918 0354813 0353104 0353705 0352746 0353487 0354216 0353915 0354542 0354690 0354875 0354151 0354522 0355219 0355499 0351896 0351998 0354374 0354730 0354923 0354800 0353898 0354486 0354056 0354952 0354213 0354342 0353964 0353717 0354837 0353406 0355368 0354941 0347736 0353823 0353827 0353465 0353595 0354174 0354492 0355152 0352954 0353203 0354649 0354365 0355158 0355492 0353546 0351478 0352263 0352265 0353735 0353747 0352455 0353472 0353990 0352910 0354442 0355491 0354477 0353848 0350752 0349020 0354936 0353182 0353910 0355258 0352741 0354222 0354224 0354314 0355354 0355457 0353524 0354129 0354537 0353495 0354822 0351981 0353313 0354333 0354928 0354897 0353656 0354006 0354090 0355187 0354122 0353983 0354546 0354934 0354002 0353397 0355160 0354304 0354581 0352577 0353030 0354254 0353046 0352985 0354874 0355129 0354026 0355346 0355431 0355570 0355220 0353002 0351811 0352037 0352376 0354614 0351800 0354185 0354248 0355733 0354270 0354105 0352799 0355126 0352886 0354038 0355498 0353395 0352788 0354249 0354080 0354152 0354751 0353317 0353468 0353654 0353473 0354188 0353326 0354473 0352906 0349619 0352571 0353360 0353426 0354015 0354307 0354101 0353652 0353869 0355010 0355698 0352948 0353559 0352380 0354650 0352891 0348392 0350639 0353181 Serial Numbers: OUS 0350255 0354385 0353821 0354323 0351187 0354283 0353298 0353715 0348897 0354012 0355089 0354076 0354634 0354504 0348956 0354636 0353926 0355203 0355232 0349138 0352586 0352734 0354977 0354645 0355355 0355208 0355034 0355503 0352434 0355665 0354811 0354861 0354316 0353620 0355251 0351845 0352009 0353775 0355608 0355195 0354282 0352607 0349828 0351048 0352403 0353033 0350960 0352275 0352587 0354409 0354287 0354383 0353804 0351991 0351546 0354071 0354550 0353299 0354397 0351118 0353842 0351132 0354066 0354984 0355338 0354322 0353922 0354239 0354120 0353713 0354682 0354536 0354258 0354398 0354728 0353639 0354182 0354402
Serial Numbers (US): 0353281 0355761 0352418 0353880 0354092 0354675 0354821 0355543 0354327 0352462 0354838 0352276 0355506 0355440 0353788 0354652 0349894 0350379 0352905 0354025 0355196 0355405 0355622 0351034 0353474 0353739 0354763 0354158 0355067 0354429 0354764 0353422 0354285 0355646 0355282 0354831 0353993 0355861 0354799 0355519 0353322 0355546 0355319 0355287 0353365 0353987 0355191 0356013 0352467 0354363 0350372 0354462 0355162 0355296 0355070 0354734 0352448 0354116 0353782 0353342 0353040 0355522 0354034 0354476 0354835 0353424 0351578 0353329 0353597 0354408 0354814 0352783 0352940 0352894 0353027 0353492 0352780 0353125 0353929 0353457 0354128 0352830 0354543 0353393 0350374 0353510 0353659 0354329 0354731 0352356 0353996 0353719 0353536 0354611 0353718 0353698 0355577 0355086 0354261 0355369 0352721 0354791 0353907 0354348 0354083 0354913 0353906 0353137 0354217 0355388 0354078 0351433 0353445 0353568 0353678 0355184 0355410 0354357 0354489 0349625 0353344 0354380 0355092 0355190 0355487 0353694 0352789 0355276 0350717 0351645 0351801 0351974 0353200 0353731 0353746 0352301 0353879 0355686 0353555 0352497 0351892 0352645 0353953 0354234 0353091 0353676 0353892 0353525 0353686 0354689 0352675 0352730 0354700 0349501 0354997 0355558 0348201 0354797 0352094 0351889 0353314 0353651 0352070 0353667 0354331 0354949 0354367 0354123 0353835 0354317 0353893 0354935 0353266 0355161 0354833 0353760 0353282 0349733 0352323 0354580 0354704 0349884 0352561 0354060 0353925 0352785 0353414 0354027 0355221 0355347 0355571 0354042 0351810 0351812 0352036 0353837 0353984 0352303 0352740 0354480 0354053 0354093 0356023 0353593 0355366 0354574 0355256 0355218 0353693 0354564 0352800 0353325 0349995 0355358 0353830 0353016 0354368 0354750 0353876 0354153 0353637 0354583 0351816 0350919 0343328 0354482 0355106 0353594 0354469 0355281 0352949 0354302 0355040 0353754 0354253 0355183 0353844 0350226 0350235 0350640 0354839 0353797 0352982 Serial Numbers: OUS 0352548 0350661 0354384 0352569 0354309 0354526 0351329 0354547 0353319 0353211 0355378 0354852 0355036 0354238 0355207 0354568 0353641 0352588 0352589 0355198 0355329 0355402 0355652 0355210 0354009 0354235 0353199 0355666 0355098 0355060 0354320 0354626 0354639 0355052 0354569 0354326 0354655 0352087 0352203 0354562 0355073 0355466 0351749 0353709 0354067 0354070 0352876 0353145 0353521 0353246 0353350 0349077 0349954 0351376 0354011 0354290 0353216 0353710 0352862 0353295 0352778 0353992 0352839 0352716 0353658 0353578 0352407 0353213 0354444 0354386 0353800 0353240 0353291 0354199 0355061 0354623 0355051 0354919 0354068 0353253 0354607 0354187 0354535 0354787 0351890 0353874 0354657 0353776 0352601 0354688 0353982 0354177 0352469 0352470 0354458 0352859 0354824 0354733 0355094 0355211 0349709 0354933 0352084 0354403 0353184
Serial Numbers (US): Left: 0353417 0353616 0354944 0353554 0348951 0354052 0351267 0352723 0353063 0353116 0352223 0351354 0353685 0354118 0354573 0351678 0354306 0355213 0354531 0352895 0353969 0354670 0352804 0353375 0353584 0353955 0353394 0354457 0354251 0354470 0353392 0351881 0353596 0352702 0354028 0354049 0352925 0354005 0354115 0354863 0352181 0354089 0353451 0354720 0352945 0353262 0353662 0353269 Right:: 0353557 0354179 0350279 0355149 0353833 0353430 0353480 0353628 0354373 0352045 0353346 0350509 0352556 0353120 0353287 0353535 0354487 0354691 0351677 0354706 0353997 0354119 0353421 0353585 0353580 0353617 0354393 0354940 0353390 0353634 0353720 0354226 0353080 0353372 0353096 0354048 0354050 0354054 0354947 0353806 0354257 0354478 0354938 0355240 0354063 0352352 0353728 0353725 0354430 0353278 0353433 0353810 0352946 0353664 0353665 0354247 Serial Numbers: (OUS) iTOTAL PSIPOLYIMPLANT KIT LEFT 0352550 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353042 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353150 ITOTAL PSIPOLYIMPLANT KIT RIGHT 0353250 ITOTAL PSIPOLYIMPLANT KIT LEFT 0353544
Serial Number: OUS 0354195
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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.