{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "221438", "product_res_number": "Z-2957-2026", "event_date_initiated": "2026-07-13", "event_date_posted": "2026-08-14", "recall_status": "Open, Classified", "res_event_number": "99372", "product_code": "SBF", "k_numbers": [ "K243950", "K243980" ], "product_description": "Brand Name: Kico Knee Innovation\nProduct Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2\nModel/Catalog Number: IN-29200\nSoftware Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200)\nARVIS Shoulder Software v2.0.3 (IN-23630)\nProduct Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. \n\n \n\nThe ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: \n\n\" Total Knee Arthroplasty \n\n\" Unicompartmental Knee Arthroplasty: Tibial Transverse Resection \n\n\" Hip Arthroplasty \n\n \n\nThe ARVIS\" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information.\nComponent: NA", "code_info": "Lot Code: GMDN - 45200\nUDI-DI - 00810180351287\n\nSoftware\nARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200)\nARVIS Shoulder Software v2.0.3 (IN-23630)\n\nSerial Number\n6006A1118\n6006A1036C3\n6006A1117\n6006A1045C2\n6006A1106\n6006A1126\n6006A1149\n6006A1034C2\n6006A1046C2\n6006A1086C2\n6006A1093\n6006A1079C3\n6006A1096C2\n6006A1052C2\n6006A1058C3\n6006A1030C2\n6006A1088\n6006A1100C\n6006A1094\n6006A1041C2\n6006A1060C3\n6006A1092C\n6006A1105\n6006A1140\n6006A1040C2\n6006A1090\n6006A1116\n6006A1109\n6006A1037C2\n6006A1053C3\n6006A1102\n6006A1108\n6006A1120\n6006A1155\n6006A1127\n6006A1139\n6006A1095C2\n6006A1131\n6006A1132\n6006A1142\n6006A1152\n6006A1193\n6006A1194\n6006A1208\n6006A1209\n6006A1107\n6006A1064C\n6006A1068C\n6006A1081C\n6006A1011C2\n 6006A1104\n6006A1101\n6006A1087C\n6006A1075C\n6006A1035C2\n6006A1057C2\n6006A1044C2\n6006A1024C2\n6006A1059C3\n6006A1083C3\n6006A1119\n6006A1124\n6006A1128\n6006A1071C2\n6006A1089\n6006A1084\n6006A1042C2\n6006A1078C2\n6006A1082C2\n6006A1027C2\n6006A1010C2\n6006A1125\n6006A1147\n6006A1025C2\n6006A1077C\n6006A1076C", "firm_fei_number": "3013552417", "recalling_firm": "Kico Knee Innovation Company", "address_1": "Suite 3, Building 1, 20 Bridge St 20 suite 3 building 1 bridge st", "city": "Pymble", "country": "Australia", "reason_for_recall": "Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing", "root_cause_description": "Device Design", "action": "On 07/13/2026, an \"Urgent: Medical Device Recall (Correction)\" Letter was email to customers informing them that, KICO has received complaints indicating that the image displayed within the ARVIS eyepiece may appear tilted relative to the eyepiece housing. The display tilt is a persistent condition rather than intermittent or periodic. When the issue occurs, the calibration parameters within an internal sensor change, resulting in a constant offset in the displayed orientation. Once this occurs, the display tilt is consistently present each time the device is powered on and used until the sensor is recalibrated and the firmware correction is implemented.\n\nCustomers are instructed to:\n1. Do not use the ARVIS Gen 2 Navigation System for any hip procedures.\n2. The ARVIS Gen 2 Navigation System may continue to be used for Knee and Shoulder procedures only, but it is recommended that all units in inventory are turned on in advance of clinical use and that any units evidencing a tilted display be returned for replacement.\n3. This notice needs to be passed on to all those who need to be aware within your organization or functions where the potentially affected devices have been transferred.\n4. This notice must be physically posted on or near all ARVIS Gen 2 Navigation Systems.\n5. Retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files.\n6. Complete the attached Acknowledgement Form immediately and return it email to Alexander.Borchardt@enovis.com\n7. The ARVIS Gen 2 Navigation System should always be visually inspected prior to use as stated in the Instructions for Use.\n8. Inform KICO of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process.\n\nFor question - contact either Sr Product Manager at Jamie.reynolds@enovis.com\n(512) 451-3815 or Sr Director, Regulatory Affairs at Sherri.Mellingen@enovis.com\n(952) 913-6383", "product_quantity": "78", "distribution_pattern": "Consignee Consignee Number Region Device Quantity\nRFK MEDICAL CE102 RICHMOND VA IN-29200, ARVIS SURGICAL NAVIGATION 1\nVALOR MEDICAL CE118 SAN ANTONIO TX IN-29200, ARVIS SURGICAL NAVIGATION 2\nJOINT VENTURES MEDICAL CE121 OSHKOSH WI IN-29200, ARVIS SURGICAL NAVIGATION 1\nCASTLE MEDICAL CE122 WATERLOO IA IN-29200, ARVIS SURGICAL NAVIGATION 6\nGREAT LAKES MEDICAL GL108 NAPERVILLE IL IN-29200, ARVIS SURGICAL NAVIGATION 2\nCERTUS MEDICAL GL112 INDIANAPOLIS IN IN-29200, ARVIS SURGICAL NAVIGATION 5\nI&S MEDICAL GL113 LOUISVILLE KY IN-29200, ARVIS SURGICAL NAVIGATION 2\nPROCORE MEDICAL MA102 PIEDMONT SC IN-29200, ARVIS SURGICAL NAVIGATION 1\nFOX MEDTECH MW001 ENGLEWOOD CO IN-29200, ARVIS SURGICAL NAVIGATION 2\nMEDSOURCE NE131 TIVERTON RI IN-29200, ARVIS SURGICAL NAVIGATION 4\nIMPLANT MEDICAL SALES NE190 HICKSVILLE NY IN-29200, ARVIS SURGICAL NAVIGATION 2\nKINETIC MEDICINE NW105 OMAHA NE IN-29200, ARVIS SURGICAL NAVIGATION 4\nCALSURG NW115 SANTA BARBARA CA IN-29200, ARVIS SURGICAL NAVIGATION 4\nMIDWEST MEDICAL RESOURCES SC181 OVERLAND PARK KS IN-29200, ARVIS SURGICAL NAVIGATION 3\nORTHO & SURGICAL SOLUTIONS SE175 GUAYNABO PR IN-29200, ARVIS SURGICAL NAVIGATION 3\nJOINT MEDICAL SOLUTIONS SE180 BIRMINGHAM AL IN-29200, ARVIS SURGICAL NAVIGATION 4\nFLT ORTHOPEDICS SE216 TAMPA FL IN-29200, ARVIS SURGICAL NAVIGATION 6\nMAC MEDICAL W180 GILBERT AZ IN-29200, ARVIS SURGICAL NAVIGATION 1\nCP ORTHO W214 HONOLULU HI IN-29200, ARVIS SURGICAL NAVIGATION 1\nUNIFIED ORTHOPEDICS W223 RIVERSIDE CA IN-29200, ARVIS SURGICAL NAVIGATION 18\nMOVEMENT MEDICAL W225 SEATTLE WA IN-29200, ARVIS SURGICAL NAVIGATION 6\nTotal number of devices in the field 78", "openfda": { "k_number": [ "K231284", "K231611", "K193559", "K242569", "K232280", "K210153", "K230567", "K202152", "K243950", "K252530", "K232176", "K220104", "K220733", "K251737", "K253805", "K252847", "K213751", "K233172", "K230789", "K220554", "K243623", "K251639", "K210859", "K242271", "K261854", "K241481", "K211188", "K220905", "K241870", "K213034", "K241525", "K223769", "K243975", "K233899", "K202750", "K250108", "K252054", "K190929", "K211254", "K252170", "K250255", "K243980", "K250477" ], "registration_number": [ "3009973505", "3016566146", "3015151147", "3008110533", "3043520095", "3006946276", "3013552417", "3033509898", "3016571711", "3016438694", "8043933", "3025287527", "3004142400", "3010197287", "9617840", "3036756245", "3016534677", "1526534", "2032098", "3006017180", "3010031846", "3019878658", "3007441485", "3014232530", "8043792", "3010163695", "3005180920", "3020703212", "3016676864", "1226544", "9681465", "3010047454", "3010407203", "3025603301", "8010468", "3008869747" ], "fei_number": [ "3009973505", "3003714383", "3016566146", "3002808269", "3015151147", "3008110533", "3043520095", "3003128516", "3013552417", "3006946276", "3033509898", "3016571711", "3016438694", "3025287527", "3004142400", "3010197287", "3002807113", "3036756245", "3016534677", "1526534", "3002806577", "3006017180", "3010031846", "3019878658", "3007441485", "3014232530", "3002619595", "3003058448", "3010163695", "3005180920", "3020703212", "3016676864", "3010047454", "3010407203", "3025603301", "3008869747" ], "device_name": "Orthopedic Augmented Reality", "medical_specialty_description": "Neurology", "regulation_number": "882.4560", "device_class": "2" } } ] }