FDAFDA · Food and drugs·Recall number Z-0671-2024
SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17V1036, 17V2036, 17V1037, 17V2037
Published January 17, 2024 · Recall initiated: September 23, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Townsend Design
- Distributor
- US: AL AR AZ CA CO CT DC DE FL GA IA ID IL IN KENT KS KY LA MA MD ME MI MN MO MS MT NC NE NH NJ NM NV NY OH OK OR PA QC SC SD TN TX UT VA VT WA WI WV WY, Puerto Rico, OUS: None OUS: Canada, New Zealand, Japan, Australia, Netherlands, United Kingdom
- Lot
- REF: 17V1030/UDI: (01)04035459407045/ Order #s 877130 871608 869477 873755 873408 873462 872532 871154 880168 880929 865865 873716 866700 870221 871517 875929 877106 877351 871959 875613 866847 882306 881541 869191 869393 875444 872004 867991 880396 868574 877787 876488 879697 866838 875675 877656 867391 873489 869196 872232 870921 867678 868728 877709 867990 879513 869349 869864 880431 879922 882026 872429 876236 871997 881374 880275 876177 869274 870606 879926 871392 878189 869601 867903 876762 867908 867780 873752 867175 872533 879230; REF: 17V2030/UDI: (01)04035459407038/ Order #s: 873689 877130 873755 873462 872532 880168 877383 881065 865865 873716 871519 875929 867520 875141 875160 867907 874430 879427 877351 875613 866847 871613 873697 874810 875444 879594 882000 867991 880396 880970 868574 868353 876488 866838 867391 873489 873231 869196 872232 876230 870921 867678 873227 877571 868728 877709 879513 869864 876395 880173 869459 872429 869390 868305 876236 880312 871997 881374 869931 870606 875391 876579 867903 876762 881372 872533 873878 879230; Ref: 17V1031/UDI: (01)04035459407069/ Order #s: 869376 877592 868548 876410 878842 881809 880881 877660 876614 882052 879617 872834 882487 878021 879707 885211 873387 876483 869443 870617 879042 880962 872482 878416 880911 866671 869932 875859 879015 879025 879592 880159 880964 876760 879612 880877 871624 866854 880364 869861 878403 871982 873934 881784 875842 879494 871626 881116 871383 880615 867163 880906 873012 879916 872027 874269 879786 869348 869509 877134 868540 869454 870916 877470 869449 870345 876431 879886 869492 871615 871474 871983 874858 870224 880370 875734 879805 884301 877916 875650 881023 870863 881420 870976 881627 871168 873674 873378 873382 874252 880193 877172 871371 881427 879725 873968 875137 880850 881995 872026 871100 874324 878077 879796 880217 873603; REF: 17V2031/UDI: (01)04035459407052/Order #s: 870883 869376 877592 876410 878842 876357 876638 866839 880881 877660 874924 867409 878010 879617 879707 885211 873387 876483 876836 869443 869362 879042 880962 871162 872482 878416 880911 866894 869932 875785 875790 875859 877250 877652 877654 880159 879612 879010 880364 878403 871982 881116 871383 879233 880906 873012 879916 879786 869348 877134 871942 868540 877470 874106 869449 870345 869395 869924 869492 871615 871983 871995 874858 870224 880370 875734 879805 884301 877916 877468 875650 877190 881023 870863 871391 870976 873518 881627 871168 873674 869351 869462 867319 874252 871225 880193 871371 872380 875375 871947 882233 877731 875137 881995 867753 862493 871100 873189 866988 876363 880217 873603; REF: 17V1032/UDI:(01)04035459407083/Order #s: 879043 871155 869394 870244 868306 869846 873447 873150 881441 878461 870616 869193 880166 879026 875477 872812 871999 869456 880378 882237 873163 866891 881632 873875 870072 871148 882041 866674 869923 871636 877108 873672 873563 878342 872015 876569 870596 870241 870870 880390 878795 879729 868544 875802 877375 869095 869379 875805 879228 879735 873688 866979 873526 875481 880184 881636 878420 872220 882084 873218 876845 878766 877986 873395 875980 869882; REF: 17V2032/UDI:(01)04035459407076/Order #s: 878742 879043 871155 875669 870618 868306 866984 872243 873447 876723 869611 877298 868547 873150 871533 872219 878461 867665 880166 880281 869857 872812 871999 880378 882220 879024 866891 877985 868946 876783 870072 871148 877701 874254 869387 874099 877069 878255 868825 881401 872015 876569 870596 866660 867675 869205 870240 870865 877578 872517 878795 866983 869329 871975 879005 873670 867673 873751 873698 873750 869095 870862 866979 873526 881636 868303 877491 872220 873218 876845 873753 878766 874799 873395 869882 879739; REF: 17V1033/UDI: (01)04035459407106 /Order #s: 879768 866975 877097 868839 873466 873690 876718 879809 873879 869591 868552 869280 870602 873397 869327 867997 872221 878458 872814 881020 869198 880565 870603 868000 869382 871273 877474 883394 878014 868870 880691 869200 874878 87
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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