{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195707", "product_res_number": "Z-1821-2022", "event_date_initiated": "2022-08-29", "event_date_posted": "2022-09-28", "recall_status": "Open, Classified", "res_event_number": "90775", "product_code": "ISW", "product_description": "OSSUR Power Knee REF PKA10003\n\nOSSUR Power Knee REF PKA10003\n\nOSSUR Power Knee REF PKA01001L\n\nOSSUR Power Knee REF PKA01001T", "code_info": "Model Number / UDI-DI Code\nPKA10001 / 05690967648381\nSerial Numbers:\nHF511081;\nHF511095;\nHF511100;\nHF511102;\nHF511116;\nHF511133;\nHF511323;\n\nPKA10003 / 05690967648749\nSerial Numbers:\nHF511029\nHF511036\nHF511042\nHF511050\nHF511060\nHF511061\nHF511065\nHF511070\nHF511071\nHF511072\nHF511075\nHF511077\nHF511082\nHF511084\nHF511096\nHF511098\nHF511099\nHF511101\nHF511104\nHF511105\nHF511108\nHF511110\nHF511115\nHF511119\nHF511121\nHF511122\nHF511123\nHF511124\nHF511126\nHF511127\nHF511128\nHF511130\nHF511131\nHF511132\nHF511136\nHF511137\nHF511138\nHF511142\nHF511144\nHF511146\nHF511148\nHF511149\nHF511151\nHF511155\nHF511159\nHF511162\nHF511163\nHF511164\nHF511165\nHF511168\nHF511169\nHF511170\nHF511171\nHF511173\nHF511176\nHF511178\nHF511179\nHF511181\nHF511182\nHF511183\nHF511185\nHF511187\nHF511188\nHF511191\nHF511192\nHF511193\nHF511194\nHF511195\nHF511198\nHF511199\nHF511200\nHF511201\nHF511204\nHF511206\nHF511207\nHF511208\nHF511212\nHF511213\nHF511216\nHF511217\nHF511218\nHF511219\nHF511221\nHF511222\nHF511223\nHF511224\nHF511225\nHF511227\nHF511228\nHF511229\nHF511230\nHF511231\nHF511234\nHF511235\nHF511236\nHF511244\nHF511245\nHF511246\nHF511247\nHF511248\nHF511250\nHF511251\nHF511253\nHF511254\nHF511255\nHF511256\nHF511257\nHF511259\nHF511260\nHF511261\nHF511262\nHF511263\nHF511264\nHF511265\nHF511267\nHF511268\nHF511269\nHF511270\nHF511274\nHF511276\nHF511277\nHF511278\nHF511279\nHF511280\nHF511281\nHF511282\nHF511283\nHF511285\nHF511286\nHF511287\nHF511293\nHF511294\nHF511295\nHF511296\nHF511298\nHF511299\nHF511300\nHF511301\nHF511302\nHF511303\nHF511306\nHF511307\nHF511308\nHF511309\nHF511311\nHF511313\nHF511314\nHF511315\nHF511318\nHF511320\nHF511321\nHF511322\nHF511325\nHF511326\nHF511327\nHF511328\nHF511338\nHF511339\nHF511340\nHF511341\nHF511342\nHF511344\nHF511345\nHF511347\nHF511348\nHF511349\nHF511350\nHF511351\nHF511352\nHF511355\nHF511356\nHF511358\nHF511360\nHF511361\nHF511362\nHF511366\nHF511367\nHF511368\nHF511369\nHF511370\nHF511372\nHF511373\nHF511376\n\n\nNote - These Models below are Loaner devices and are under Firm's control\nPKA01001L / 05690967642822\nSerial Numbers:\nHF511037\nHF511091\nHF511324\nHF511143\nHF511363\nHF511375\nHF511377\nHF511378\nHF511184\nHF511203\nHF511237\nHF511252\nHF511273\nHF511275\nHF511304\nHF511330\nHF511374\nHF511047\nHF511094\n\nPKA01001T / 05690967642839\nSerial Numbers:\nHF511177\nHF511059\nHF511038\nHF511054\nHF511058\nHF511046\nHF511064\nHF511080\nHF511073\nHF511076\nHF511079\nHF511028\nHF511249\nHF511240\nHF511241\nHF511196\nHF511051\nHF511135", "firm_fei_number": "1000519909", "recalling_firm": "Ossur Americas", "address_1": "27051 Towne Centre Dr", "city": "Foothill Ranch", "state": "CA", "postal_code": "92610-2804", "additional_info_contact": "Chris Lohrman\n949-382-3715 Ext. 102", "reason_for_recall": "Battery may dislodge from the Power Knee", "root_cause_description": "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.\n\nCustomer 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:\n1. Pass this notice to those who need to be aware within their organization or to any organization where Power Knee devices have been transferred.\n2. Reconcile Ossur s records with their own to ensure all devices are accounted.\n3. 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.\n4. Sign the acknowledgment form confirming receipt of this notice and that the retrofit process has been completed for all affected devices.\n\nOssur is here to support customers through the process. Contact customer service for further information and assistance. Tel: 1-800-233-6263.", "product_quantity": "190 devices", "distribution_pattern": "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.", "openfda": { "k_number": [ "K991590" ], "registration_number": [ "3014827594", "3010220187", "3003855936", "3004134478", "3027645766", "3006943846", "3004737223", "1721652", "3007123908", "3008584163" ], "fei_number": [ "3014827594", "3010220187", "3003855936", "3004134478", "3027645766", "3006943846", "3004737223", "1721652", "3007123908", "3008584163" ], "device_name": "Assembly, Knee/Shank/Ankle/Foot, External", "medical_specialty_description": "Physical Medicine", "regulation_number": "890.3500", "device_class": "2" } } ] }