Townsend Design: SPRYSTEP VECTOR, Custom made device dynamic ankle-foot orthosis (AFO) , Reference numbers: 17V1030, 17V2030, 17V1031, 17V2031, 17V1032, 17V2032, 17V1033, 17V2033, 17V1035, 17V2035, 17

Hazard

Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.

Details from the source

Reason for recall: Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. Distribution: 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 Quantity: 898 units Lot/code info: 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 8720

UPC codes

04035459407045, 04035459407038, 04035459407069, 04035459407052, 04035459407083, 04035459407076, 04035459407106, 04035459407090, 04035459414517, 04035459414500, 04035459414531, 04035459414524, 04035459414555, 04035459414548

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.