{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "204706", "product_res_number": "Z-0788-2024", "event_date_initiated": "2023-12-26", "event_date_posted": "2024-01-25", "recall_status": "Open, Classified", "res_event_number": "93549", "product_code": "ISW", "product_description": "Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002", "code_info": "REF/UDI-DI: PKA10001/05690967648381, PKA10003/05690967648749, PKA10002/05690967648404.\nKnee/Battery Serial Numbers:\nHF511036\tHF551398,\nHF511050\tHF551935,\nHF511065\tHF552267,\nHF511072\tHF551258,\nHF511081\tHF552479,\nHF511082\tHF551327,\nHF511084\tHF552406,\nHF511096\tHF551301,\nHF511098\tHF551215,\nHF511099\tHF551366,\nHF511104\tHF551409,\nHF511105\tHF552404,\nHF511119\tHF551282,\nHF511121\tHF552298,\nHF511122\tHF551400,\nHF511123\tHF552314,\nHF511124\tHF552333,\nHF511128\tHF552414,\nHF511130\tHF552339,\nHF511131\tHF552315,\nHF511132\tHF552271,\nHF511133\tHF552268,\nHF511136\tHF552316,\nHF511137\tHF552332,\nHF511138\tHF552310,\nHF511139\tHF552483,\nHF511142\tHF552294,\nHF511144\tHF551368,\nHF511148\tHF552401,\nHF511149\tHF552317,\nHF511150\tHF552471,\nHF511151\tHF552251,\nHF511163\tHF552394,\nHF511164\tHF552311,\nHF511165\tHF552470,\nHF511168\tHF552326,\nHF511169\tHF551279,\nHF511170\tHF552309,\nHF511171\tHF552407,\nHF511173\tHF551477,\nHF511178\tHF552485,\nHF511179\tHF551344,\nHF511181\tHF552392,\nHF511182\tHF551347,\nHF511183\tHF551275/HF552399,\nHF511185\tHF552290,\nHF511187\tHF552331,\nHF511188\tHF552256,\nHF511191\tHF552249,\nHF511192\tHF552308,\nHF511193\tHF551346,\nHF511194\tHF552284,\nHF511195\tHF551216,\nHF511198\tHF552241,\nHF511199\tHF551321,\nHF511200\tHF552335,\nHF511201\tHF552260,\nHF511242\tHF551226,\nHF511257\tHF552327,\nHF511267\tHF552277,\nHF511277\tHF552305,\nHF511278\tHF552325,\nHF511279\tHF552245,\nHF511280\tHF552323,\nHF511281\tHF552255,\nHF511282\tHF552328,\nHF511283\tHF552296,\nHF511293\tHF551406,\nHF511294\tHF551380,\nHF511295\tHF552487,\nHF511296\tHF552408,\nHF511298\tHF551413,\nHF511299\tHF552299,\nHF511302\tHF551399,\nHF511303\tHF552264,\nHF511306\tHF551337,\nHF511307\tHF552337,\nHF511308\tHF552248,\nHF511309\tHF552340,\nHF511311\tHF552263,\nHF511313\tHF552307,\nHF511314\tHF552261,\nHF511315\tHF552478,\nHF511318\tHF552475,\nHF511319\tHF552280,\nHF511320\tHF552324,\nHF511321\tHF552312,\nHF511322\tHF552320,\nHF511323\tHF552259,\nHF511325\tHF551389,\nHF511326\tHF551218,\nHF511327\tHF551367,\nHF511328\tHF552301,\nHF511339\tHF552322,\nHF511341\tHF552286,\nHF511342\tHF552473,\nHF511344\tHF551527,\nHF511345\tHF551223,\nHF511347\tHF551271,\nHF511348\tHF552468,\nHF511351\tHF551219,\nHF511355\tHF552289,\nHF511358\tHF552275,\nHF511360\tHF551888,\nHF511362\tHF552476,\nHF511364\tHF552415,\nHF511366\tHF552472,\nHF511367\tHF552480,\nHF511368\tHF552490,\nHF511369\tHF552489,\nHF511372\tHF551837,\nHF511373\tHF552273,\nHF511376\tHF552395,\nHF511381\tHF551524,\nHF511383\tHF552269,\nHF511384\tHF551924,\nHF511385\tHF551372,\nHF511388\tHF552183,\nHF511389\tHF552398,\nHF511390\tHF551487,\nHF511391\tHF551681,\nHF511392\tHF552411,\nHF511393\tHF552170,\nHF511394\tHF551737,\nHF511395\tHF552179,\nHF511396\tHF551660,\nHF511397\tHF552182,\nHF511398\tHF551842,\nHF511399\tHF551553,\nHF511400\tHF552474,\nHF511401\tHF551952,\nHF511403\tHF551556,\nHF511404\tHF552272,\nHF511406\tHF552410,\nHF511407\tHF552293,\nHF511408\tHF551396,\nHF511409\tHF551908,\nHF511410\tHF552276,\nHF511411\tHF552412,\nHF511412\tHF552481,\nHF511413\tHF552409,\nHF511416\tHF551779,\nHF511417\tHF552229,\nHF511418\tHF552146,\nHF511419\tHF552173,\nHF511420\tHF551946,\nHF511423\tHF551937,\nHF511424\tHF551628,\nHF511425\tHF551696,\nHF511426\tHF552405,\nHF511427\tHF551533,\nHF511428\tHF552482,\nHF511429\tHF551558,\nHF511430\tHF552338,\nHF511431\tHF552318,\nHF511432\tHF551680,\nHF511433\tHF551543,\nHF511434\tHF551949,\nHF511435\tHF551727,\nHF511436\tHF551532,\nHF511439\tHF552363,\nHF511440\tHF551894,\nHF511442\tHF551671,\nHF511444\tHF551945,\nHF511445\tHF551522,\nHF511450\tHF551907,\nHF511452\tHF552469,\nHF511454\tHF551977,\nHF511455\tHF552288,\nHF511456\tHF551332,\nHF511457\tHF551343,\nHF511458\tHF552466,\nHF511459\tHF551928,\nHF511460\tHF551643,\nHF511463\tHF551933,\nHF511464\tHF551972,\nHF511465\tHF552043,\nHF511466\tHF551958,\nHF511468\tHF552300,\nHF511469\tHF552285,\nHF511470\tHF552413,\nHF511471\tHF551903,\nHF511472\tHF551904,\nHF511473\tHF551941,\nHF511474\tHF551943,\nHF511475\tHF551944,\nHF511476\tHF551947,\nHF511477\tHF551393,\nHF511479\tHF551905,\nHF511482\tHF551663,\nHF511484\tHF551898,\nHF511485\tHF551710,\nHF511486\tHF551987,\nHF511488\tHF551985,\nHF511491\tHF551959,\nHF511492\tHF551423,\nHF511493\tHF551980,\nHF511495\tHF551899,\nHF511496\tHF551983,\nHF511500\tHF552330,\nHF511501\tHF551979,\nHF511502\tHF551951,\nHF511503\tHF551916,\nHF511504\tHF551554,\nHF511505\tHF551700,\nHF511506\tHF551376/HF551971,\nHF511507\tHF551730,\nHF511508\tHF551518,\nHF511509\tHF551549,\nHF511511\tHF551550,\nHF511513\tHF551975,\nHF511515\tHF552391,\nHF511516\tHF551370,\nHF511518\tHF551954,\nHF511519\tHF552396,\nHF511521\tHF551653,\nHF511523\tHF551470,\nHF511524\tHF551545,\nHF511526\tHF551689,\nHF511528\tHF551531,\nHF511532\tHF551976,\nHF511533\tHF551965,\nHF511534\tHF551724,\nHF511536\tHF551564,\nHF511538\tHF551709,\nHF511539\tHF551546,\nHF511540\tHF552283,\nHF511541\tHF552265,\nHF511542\tHF551731,\nHF511543\tHF551843,\nHF511545\tHF551719,\nHF511546\tHF551541,\nHF511548\tHF552187,\nHF511550\tHF552166,\nHF511551\tHF552477,\nHF511557\tHF551751,\nHF511558\tHF552151,\nHF511561\tHF551896,\nHF511562\tHF552174,\nHF511563\tHF551565,\nHF511565\tHF551703,\nHF511566\tHF551953,\nHF511567\tHF551288,\nHF511568\tHF551350/HF551375,\nHF511570\tHF552188,\nHF511574\tHF551387/HF551957,\nHF511575\tHF552185,\nHF511576\tHF552141,\nHF511579\tHF552171,\nHF511580\tHF551642,\nHF511581\tHF551803,\nHF511582\tHF551539,\nHF511585\tHF551895/HF552291,\nHF511587\tHF551383/HF552175,\nHF511589\tHF551536,\nHF511590\tHF551902,\nHF511591\tHF551960,\nHF511594\tHF551544,\nHF511595\tHF552319,\nHF511601\tHF551317/HF551458,\nHF511602\tHF551658,\nHF511603\tHF551629,\nHF511604\tHF552148,\nHF511605\tHF551555,\nHF511607\tHF551750,\nHF511613\tHF551909,\nHF511614\tHF551560,\nHF511616\tHF552178,\nHF511618\tHF551887,\nHF511623\tHF551984,\nHF511628\tHF551884,\nHF511630\tHF551922,\nHF511636\tHF552254,\nHF511638\tHF551616,\nHF511646\tHF552361,\nHF511653\tHF551220/HF552257,\nHF511655\tHF552397,\nHF511661\tHF551940,\nHF511662\tHF551479,\nHF511663\tHF551363,\nHF511664\tHF552242,\nHF511675\tHF551233,\nHF511681\tHF551354,\nHF511683\tHF552364,\nHF511697\tHF551401,\nHF511704\tHF551306,\nHF511706\tHF551326,\nHF511729\tHF551437,\nHF511735\tHF551369,\nHF511737\tHF551440,\nHF511740\tHF551392,\nHF511747\tHF551237,\nHF511748\tHF551431,\nHF511753\tHF551385,\nHF511755\tHF552352,\nHF511756\tHF551478,\nHF511757\tHF551397,\nHF511758\tHF551434,\nHF511759\tHF551490,\nHF511760\tHF551230,\nHF511761\tHF551430,\nHF511766\tHF551426,\nHF511768\tHF551381,\nHF511770\tHF551447,\nHF511771\tHF551263,\nHF511774\tHF551488,\nHF511775\tHF552402,\nHF511776\tHF551265,\nHF511777\tHF552365,\nHF511780\tHF551231,\nHF511781\tHF551329,\nHF511785\tHF551342,\nHF511786\tHF551316,\nHF511788\tHF551351,\nHF511789\tHF551473,\nHF511790\tHF551408,\nHF511794\tHF551334/HF552329,\nHF511795\tHF551331,\nHF511797\tHF552356,\nHF511801\tHF551450,\nHF511802\tHF551474,\nHF511807\tHF552346,\nHF511808\tHF550808,\nHF511810\tHF551250,\nHF511811\tHF551248,\nHF511812\tHF551259,\nHF511813\tHF551323,\nHF511816\tHF551357,\nHF511817\tHF551217,\nHF511818\tHF551247/HF551673,\nHF511819\tHF551341,\nHF511820\tHF551462,\nHF511821\tHF551205,\nHF511822\tHF551302,\nHF511824\tHF551254,\nHF511825\tHF551333,\nHF511826\tHF551340,\nHF511828\tHF551269,\nHF511829\tHF551264,\nHF511830\tHF551419,\nHF511831\tHF551433,\nHF511832\tHF551460,\nHF511835\tHF551314,\nHF511836\tHF551438,\nHF511838\tHF551455,\nHF511839\tHF551362,\nHF511847\tHF551361,\nHF511848\tHF551436,\nHF511849\tHF551429,\nHF511851\tHF551241,\nHF511852\tHF551224,\nHF511853\tHF551255,\nHF511858\tHF551228,\nHF511859\tHF551336,\nHF511860\tHF551280,\nHF511861\tHF551234,\nHF511864\tHF551384,\nHF511867\tHF551442,\nHF511868\tHF552297,\nHF511869\tHF551466,\nHF511870\tHF551298,\nHF511877\tHF551421,\nHF511878\tHF551311,\nHF511881\tHF551287,\nHF511883\tHF551459,\nHF511884\tHF551374,\nHF511885\tHF551806,\nHF511886\tHF552357,\nHF511888\tHF551274,\nHF511889\tHF551266,\nHF511890\tHF551240,\nHF511891\tHF552347,\nHF511892\tHF551232,\nHF511893\tHF552304,\nHF511900\tHF551394,\nHF511901\tHF551428,\nHF511902\tHF551277,\nHF511904\tHF551355,\nHF511905\tHF551446,\nHF511908\tHF551348,\nHF511909\tHF551235,\nHF511910\tHF551296,\nHF511913\tHF551278,\nHF511919\tHF552295,\nHF511920\tHF551443,\nHF511924\tHF551481,\nHF511925\tHF551283,\nHF511928\tHF551273,\nHF511930\tHF551410,\nHF511931\tHF551427,\nHF511932\tHF551386,\nHF511933\tHF551449,\nHF511935\tHF551468,\nHF511936\tHF551483,\nHF511938\tHF551828,\nHF511940\tHF551319,\nHF511948\tHF551463,\nHF511950\tHF551771,\nHF511951\tHF551453,\nHF511952\tHF551244,\nHF511953\tHF551420,\nHF511956\tHF551467,\nHF511957\tHF551294,\nHF511958\tHF551339,\nHF511959\tHF551742,\nHF511960\tHF551284,\nHF511961\tHF551293,\nHF511962\tHF551412,\nHF511966\tHF552302,\nHF511967\tHF552342,\nHF511969\tHF551324,\nHF511973\tHF551252,\nHF511974\tHF552244,\nHF511975\tHF551246,\nHF511976\tHF551300,\nHF511977\tHF551295,\nHF511981\tHF552253,\nHF511982\tHF552243,\nHF511984\tHF551882,\nHF511985\tHF552246,\nHF511986\tHF551860,\nHF511987\tHF551289,\nHF511988\tHF552292,\nHF511989\tHF551461,\nHF511990\tHF551297,\nHF511991\tHF551793,\nHF511993\tHF551881,\nHF511994\tHF551320,\nHF511997\tHF551286,\nHF512000\tHF551451,\nHF512001\tHF551805,\nHF512002\tHF551418,\nHF512003\tHF552358,\nHF512005\tHF552341,\nHF512006\tHF551435,\nHF512007\tHF551464,\nHF512008\tHF551382,\nHF512009\tHF551270,\nHF512010\tHF551222,\nHF512011\tHF551785,\nHF512012\tHF551814,\nHF512016\tHF552282,\nHF512018\tHF551845,\nHF512023\tHF552252,\nHF512024\tHF551229,\nHF512025\tHF551870,\nHF512027\tHF551318,\nHF512035\tHF551886,\nHF512036\tHF551829,\nHF512037\tHF551847,\nHF512038\tHF552281,\nHF512039\tHF551746,\nHF512040\tHF551791,\nHF512041\tHF551448,\nHF512042\tHF551782,\nHF512043\tHF551800,\nHF512047\tHF551801,\nHF512051\tHF551753,\nHF512052\tHF551774,\nHF512053\tHF551865,\nHF512054\tHF551868,\nHF512055\tHF551749,\nHF512056\tHF551841,\nHF512057\tHF552486,\nHF512058\tHF551480/HF552250,\nHF512060\tHF551780,\nHF512075\tHF551880,\nHF512076\tHF551834,\nHF512077\tHF551879,\nHF512081\tHF551799,\nHF512082\tHF551811,\nHF512085\tHF551769,\nHF512086\tHF551858,\nHF512090\tHF551765,\nHF512091\tHF551863,\nHF512092\tHF551825,\nHF512093\tHF551862,\nHF512094\tHF551831,\nHF512095\tHF551822,\nHF512096\tHF551815,\nHF512097\tHF551358,\nHF512098\tHF551804,\nHF512106\tHF551773,\nHF512109\tHF551593,\nHF512111\tHF551826,\nHF512112\tHF551838,\nHF512117\tHF551827,\nHF512121\tHF551754,\nHF512129\tHF551652,\nHF512130\tHF551770,\nHF512131\tHF551963,\nHF512132\tHF551760,\nHF512139\tHF551646,\nHF512146\tHF551819,\nHF512150\tHF551654,\nHF512151\tHF551970,\nHF512152\tHF551650,\nHF512154\tHF551647,\nHF512156\tHF551649,\nHF512157\tHF551809,\nHF512160\tHF551969,\nHF512161\tHF551645,\nHF512164\tHF551636,\nHF512165\tHF551723,\nHF512166\tHF552228,\nHF512167\tHF551552,\nHF512168\tHF552222,\nHF512170\tHF551607,\nHF512175\tHF551624,\nHF512176\tHF551684,\nHF512177\tHF551725,\nHF512178\tHF552237,\nHF512180\tHF551722,\nHF512181\tHF551735,\nHF512184\tHF551755,\nHF512186\tHF551618,\nHF512187\tHF551752,\nHF512188\tHF551547,\nHF512189\tHF551885,\nHF512190\tHF551854,\nHF512191\tHF551761,\nHF512192\tHF551807,\nHF512193\tHF551633,\nHF512198\tHF551821,\nHF512199\tHF551718,\nHF512203\tHF551740,\nHF512204\tHF551929,\nHF512207\tHF551537,\nHF512209\tHF551677,\nHF512210\tHF551920,\nHF512212\tHF551925,\nHF550746\tHF551245,\nHF551111\tHF551414,", "firm_fei_number": "3003764610", "recalling_firm": "Ossur H / F", "address_1": "Grjothals 5 5 grjothals", "city": "Reykjavik", "country": "Iceland", "additional_info_contact": "Joshua Portman\n800-233-6263 Ext. 10", "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.", "root_cause_description": "Process control", "action": "On 12/26/23, recall notices were mailed to customers who were asked to do the following: \na. Check the serial number of the Power Knee Batteries to confirm the affected units.\nb. Replace the affected batteries with the new batteries supplied along with this letter.\nc. To ensure future traceability, please fit each new battery into the designated knee according to the knee Serial Number indicated on the sticker on the back of the battery.\nd. PASS THIS NOTICE to those who need to be aware within your organization. If you have further distributed this product, please identify your customers, and notify them at once of this product alert. We recommend that you include a copy of this notice.\ne. Complete and return acknowledgement forms and affected batteries in pre-paid return packaging provided.\n\nCustomers with questions can contact customer service at 1-800-233-6263, extension 10", "product_quantity": "544 Batteries", "distribution_pattern": "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.", "openfda": { "k_number": [ "K991590" ], "registration_number": [ "3003855936", "3014827594", "3007123908", "3010220187", "3008584163", "3027645766", "1721652", "3004737223", "3006943846", "3004134478" ], "fei_number": [ "3003855936", "3014827594", "3007123908", "3010220187", "3008584163", "3027645766", "1721652", "3004737223", "3006943846", "3004134478" ], "device_name": "Assembly, Knee/Shank/Ankle/Foot, External", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3500", "device_class": "2" } } ] }