Due to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis.
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: 334 units Lot/code info: REF: 17VKCUS:UDI: /Order #s: 868003 864980 877514 867899 875411 875411 868308 871161 865211 881621 872534 881616 865744 866309 876670 877270 864959 869294 868549 864957 864595 866551 866682 863308 875500 873400 865509 868828 875846 877677 869358 876200 873155 867381 878188 870222 870222 869927 873860 873860 865503 878668 878182 863772 866842 878791 865507 863707 872687 868289 873685 870922 870922 864367 865966 875463 871512 871512 870916 866919 879216 878252 879014 874428 867045 878412 863471 871544 874438 872200 870646 872512 865508 865508 876593 869370 865720 863470 876045 867371 865737 868736 873157 867694 875149 867457 875554 863353 867286 873781 873357 867357 873861 871137 REF: 17VKCUSX: UDI:/Order #s: 873093 877251 877251 864343 864343 876329 867359 867359 876421 867376 868295 863890 873575 868834 874561 874561 877602 877602 872207 872835 864342 867052 874879 878550 865056 865056 879221 877567 882074 871827 871827 865201 877909 877909 869372 869374 866576 867687 874242 876221 876221 874239 877527 868310 864590 872312 872312 874217 874217 875682 875682 875682 875682 865743 864949 864949 864960 872833 872535 872535 870881 870881 875053 875053 877459 866653 876099 870214 873791 873025 863340 866810 868042 868534 869716 871539 874028 877634 865745 876675 872003 873863 874082 875898 873401 878664 871403 872028 865207 870243 873579 874453 874453 867886 878116 867382 871008 878134 865464 865464 867932 872463 872463 876902 876902 868831 869045 867147 865504 872823 871992 875377
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.