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FDA (Device enforcement)Recalled 2022-08-29class ii

Ossur Americas: OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA01001L OSSUR Power Knee REF PKA01001T

Hazard

Battery may dislodge from the Power Knee

Details from the source

Reason for recall: Battery may dislodge from the Power Knee Distribution: U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, VA, VT, WA and WI. Quantity: 190 devices Lot/code info: Model Number / UDI-DI Code PKA10001 / 05690967648381 Serial Numbers: HF511081; HF511095; HF511100; HF511102; HF511116; HF511133; HF511323; PKA10003 / 05690967648749 Serial Numbers: HF511029 HF511036 HF511042 HF511050 HF511060 HF511061 HF511065 HF511070 HF511071 HF511072 HF511075 HF511077 HF511082 HF511084 HF511096 HF511098 HF511099 HF511101 HF511104 HF511105 HF511108 HF511110 HF511115 HF511119 HF511121 HF511122 HF511123 HF511124 HF511126 HF511127 HF511128 HF511130 HF511131 HF511132 HF511136 HF511137 HF511138 HF511142 HF511144 HF511146 HF511148 HF511149 HF511151 HF511155 HF511159 HF511162 HF511163 HF511164 HF511165 HF511168 HF511169 HF511170 HF511171 HF511173 HF511176 HF511178 HF511179 HF511181 HF511182 HF511183 HF511185 HF511187 HF511188 HF511191 HF511192 HF511193 HF511194 HF511195 HF511198 HF511199 HF511200 HF511201 HF511204 HF511206 HF511207 HF511208 HF511212 HF511213 HF511216 HF511217 HF511218 HF511219 HF511221 HF511222 HF511223 HF511224 HF511225 HF511227 HF511228 HF511229 HF511230 HF511231 HF511234 HF511235 HF511236 HF511244 HF511245 HF511246 HF511247 HF511248 HF511250 HF511251 HF511253 HF511254 HF511255 HF511256 HF511257 HF511259 HF511260 HF511261 HF511262 HF511263 HF511264 HF511265 HF511267 HF511268 HF511269 HF511270 HF511274 HF511276 HF511277 HF511278 HF511279 HF511280 HF511281 HF511282 HF511283 HF511285 HF511286 HF511287 HF511293 HF511294 HF511295 HF511296 HF511298 HF511299 HF511300 HF511301 HF511302 HF511303 HF511306 HF511307 HF511308 HF511309 HF511311 HF511313 HF511

UPC codes

05690967648381, 05690967648749, 05690967642822, 05690967642839

Source

Official record: FDA (Device enforcement)

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

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