Ossur H / F: Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002

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.

Details from the source

Reason for recall: 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. Distribution: 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. Quantity: 544 Batteries Lot/code info: 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, HF51129

UPC codes

05690967648381, 05690967648749, 05690967648404

Source

Official record: FDA (Device enforcement) ↗

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