FDAFDA · Food and drugs·Recall number Z-0788-2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
Published January 31, 2024 · Recall initiated: December 26, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Knee batteries may need replacement with conforming batteries to ensure there isn't a failure to turn on the device, or an unexpected shutdown, which is a momentary loss of power to the knee where the user may experience loss of support that can lead to a fall and potential injury.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ossur H / F
- Distributor
- US Nationwide distribution including in the states of MA, SC, MD, TN, ND, VA, IL, NJ, FL, MI, NY, AL, TX, OK, IN, GA, CA, PA, NM, VT, NV, MS, HI, OH, WI, LA, IA, NE, MN, AR, OR, NC, NH, WV, CO, ID, AZ, MO, CT, WA, KY, UT, KS.
- Lot
- REF/UDI-DI: PKA10001/05690967648381, PKA10003/05690967648749, PKA10002/05690967648404. Knee/Battery Serial Numbers: HF511036 HF551398, HF511050 HF551935, HF511065 HF552267, HF511072 HF551258, HF511081 HF552479, HF511082 HF551327, HF511084 HF552406, HF511096 HF551301, HF511098 HF551215, HF511099 HF551366, HF511104 HF551409, HF511105 HF552404, HF511119 HF551282, HF511121 HF552298, HF511122 HF551400, HF511123 HF552314, HF511124 HF552333, HF511128 HF552414, HF511130 HF552339, HF511131 HF552315, HF511132 HF552271, HF511133 HF552268, HF511136 HF552316, HF511137 HF552332, HF511138 HF552310, HF511139 HF552483, HF511142 HF552294, HF511144 HF551368, HF511148 HF552401, HF511149 HF552317, HF511150 HF552471, HF511151 HF552251, HF511163 HF552394, HF511164 HF552311, HF511165 HF552470, HF511168 HF552326, HF511169 HF551279, HF511170 HF552309, HF511171 HF552407, HF511173 HF551477, HF511178 HF552485, HF511179 HF551344, HF511181 HF552392, HF511182 HF551347, HF511183 HF551275/HF552399, HF511185 HF552290, HF511187 HF552331, HF511188 HF552256, HF511191 HF552249, HF511192 HF552308, HF511193 HF551346, HF511194 HF552284, HF511195 HF551216, HF511198 HF552241, HF511199 HF551321, HF511200 HF552335, HF511201 HF552260, HF511242 HF551226, HF511257 HF552327, HF511267 HF552277, HF511277 HF552305, HF511278 HF552325, HF511279 HF552245, HF511280 HF552323, HF511281 HF552255, HF511282 HF552328, HF511283 HF552296, HF511293 HF551406, HF511294 HF551380, HF511295 HF552487, HF511296 HF552408, HF511298 HF551413, HF511299 HF552299, HF511302 HF551399, HF511303 HF552264, HF511306 HF551337, HF511307 HF552337, HF511308 HF552248, HF511309 HF552340, HF511311 HF552263, HF511313 HF552307, HF511314 HF552261, HF511315 HF552478, HF511318 HF552475, HF511319 HF552280, HF511320 HF552324, HF511321 HF552312, HF511322 HF552320, HF511323 HF552259, HF511325 HF551389, HF511326 HF551218, HF511327 HF551367, HF511328 HF552301, HF511339 HF552322, HF511341 HF552286, HF511342 HF552473, HF511344 HF551527, HF511345 HF551223, HF511347 HF551271, HF511348 HF552468, HF511351 HF551219, HF511355 HF552289, HF511358 HF552275, HF511360 HF551888, HF511362 HF552476, HF511364 HF552415, HF511366 HF552472, HF511367 HF552480, HF511368 HF552490, HF511369 HF552489, HF511372 HF551837, HF511373 HF552273, HF511376 HF552395, HF511381 HF551524, HF511383 HF552269, HF511384 HF551924, HF511385 HF551372, HF511388 HF552183, HF511389 HF552398, HF511390 HF551487, HF511391 HF551681, HF511392 HF552411, HF511393 HF552170, HF511394 HF551737, HF511395 HF552179, HF511396 HF551660, HF511397 HF552182, HF511398 HF551842, HF511399 HF551553, HF511400 HF552474, HF511401 HF551952, HF511403 HF551556, HF511404 HF552272, HF511406 HF552410, HF511407 HF552293, HF511408 HF551396, HF511409 HF551908, HF511410 HF552276, HF511411 HF552412, HF511412 HF552481, HF511413 HF552409, HF511416 HF551779, HF511417 HF552229, HF511418 HF552146, HF511419 HF552173, HF511420 HF551946, HF511423 HF551937, HF511424 HF551628, HF511425 HF551696, HF511426 HF552405, HF511427 HF551533, HF511428 HF552482, HF511429 HF551558, HF511430 HF552338, HF511431 HF552318, HF511432 HF551680, HF511433 HF551543, HF511434 HF551949, HF511435 HF551727, HF511436 HF551532, HF511439 HF552363, HF511440 HF551894, HF511442 HF551671, HF511444 HF551945, HF511445 HF551522, HF511450 HF551907, HF511452 HF552469, HF511454 HF551977, HF511455 HF552288, HF511456 HF551332, HF511457 HF551343, HF511458 HF552466, HF511459 HF551928, HF511460 HF551643, HF511463 HF551933, HF511464 HF551972, HF511465 HF552043, HF511466 HF551958, HF511468 HF552300, HF511469 HF552285, HF511470 HF552413, HF511471 HF551903, HF511472 HF551904, HF511473 HF551941, HF511474 HF551943, HF511475 HF551944, HF511476 HF551947, HF511477 HF551393, HF511479 HF551905, HF511482 HF551663, HF511484 HF551898, HF511485 HF551710, HF511486 HF551987, HF511488 HF551985, HF511491 HF551959, HF511492 HF551423, HF511493 HF551980, HF511495 HF551899, HF511496 HF551983, HF511500 HF552330, HF511501 HF551979, HF511502 HF551951, HF511503 HF551916, HF511504 HF551554,
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Iceland
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