medical MODERATE Updated 2026-08-26

Kico Knee Innovation Company recalls Brand Name: Kico Knee Innovation Product Name: ARVIS SURGIC

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Recalled Product

Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product 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. The 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: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The 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. Component: NA

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Hazard / Issue

Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing

Issued by

FDA

Affected States: VA, IN, TX, WI, IA, IL, KY, SC, CO, RI, NY, NE, CA, KS, AL, FL, AZ, HI, WA
Lot/Code Info: Lot Code: GMDN - 45200 UDI-DI - 00810180351287 Software ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Serial Number 6006A1118 6006A1036C3 6006A1117 6006A1045C2 6006A1106 6006A1126 6006A1149 6006A1034C2 6006A1046C2 6006A1086C2 6006A1093 6006A1079C3 6006A1096C2 6006A1052C2 6006A1058C3 6006A1030C2 6006A1088 6006A1100C 6006A1094 6006A1041C2 6006A1060C3 6006A1092C 6006A1105 6006A1140 6006A1040C2 6006A1090 6006A1116 6006A1109 6006A1037C2 6006A1053C3 6006A1102 6006A1108 6006A1120 6006A1155 6006A1127 6006A1139 6006A1095C2 6006A1131 6006A1132 6006A1142 6006A1152 6006A1193 6006A1194 6006A1208 6006A1209 6006A1107 6006A1064C 6006A1068C 6006A1081C 6006A1011C2 6006A1104 6006A1101 6006A1087C 6006A1075C 6006A1035C2 6006A1057C2 6006A1044C2 6006A1024C2 6006A1059C3 6006A1083C3 6006A1119 6006A1124 6006A1128 6006A1071C2 6006A1089 6006A1084 6006A1042C2 6006A1078C2 6006A1082C2 6006A1027C2 6006A1010C2 6006A1125 6006A1147 6006A1025C2 6006A1077C 6006A1076C

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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