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U.S. Department of Health and Human Services

Class 2 Device Recall Power Knee

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  Class 2 Device Recall Power Knee see related information
Date Initiated by Firm August 29, 2022
Date Posted September 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1821-2022
Recall Event ID 90775
Product Classification Assembly, knee/shank/ankle/foot, external - Product Code ISW
Product OSSUR Power Knee REF PKA10003

OSSUR Power Knee REF PKA10003

OSSUR Power Knee REF PKA01001L

OSSUR Power Knee REF PKA01001T
Code Information 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 HF511314 HF511315 HF511318 HF511320 HF511321 HF511322 HF511325 HF511326 HF511327 HF511328 HF511338 HF511339 HF511340 HF511341 HF511342 HF511344 HF511345 HF511347 HF511348 HF511349 HF511350 HF511351 HF511352 HF511355 HF511356 HF511358 HF511360 HF511361 HF511362 HF511366 HF511367 HF511368 HF511369 HF511370 HF511372 HF511373 HF511376 Note - These Models below are Loaner devices and are under Firm's control PKA01001L / 05690967642822 Serial Numbers: HF511037 HF511091 HF511324 HF511143 HF511363 HF511375 HF511377 HF511378 HF511184 HF511203 HF511237 HF511252 HF511273 HF511275 HF511304 HF511330 HF511374 HF511047 HF511094 PKA01001T / 05690967642839 Serial Numbers: HF511177 HF511059 HF511038 HF511054 HF511058 HF511046 HF511064 HF511080 HF511073 HF511076 HF511079 HF511028 HF511249 HF511240 HF511241 HF511196 HF511051 HF511135
Recalling Firm/
Ossur Americas
27051 Towne Centre Dr
Foothill Ranch CA 92610-2804
For Additional Information Contact Chris Lohrman
949-382-3715 Ext. 102
Manufacturer Reason
for Recall
Battery may dislodge from the Power Knee
FDA Determined
Cause 2
Device Design
Action On 08/29/2022, The firm sent via email an "URGENT MEDICAL DEVICE CORRECTION" Letter informing customers that reports have been received of units where the battery dislodged from the Power Knee units, causing loss of power to the device. This may cause an increase risk for stumbles or falls, potentially leading to an injury. Customer are being instructed to implement a correction to retrofit a security tab to their units. The retrofit kit will be provided with clear instructions for attaching the security tab to the device. In addition, customer are asked to: 1. Pass this notice to those who need to be aware within their organization or to any organization where Power Knee devices have been transferred. 2. Reconcile Ossur s records with their own to ensure all devices are accounted. 3. Once all users have been identified and the retrofit kits have been received, customers will need to schedule each individual to come into their clinic to complete the retrofit process. 4. Sign the acknowledgment form confirming receipt of this notice and that the retrofit process has been completed for all affected devices. Ossur is here to support customers through the process. Contact customer service for further information and assistance. Tel: 1-800-233-6263.
Quantity in Commerce 190 devices
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.