United StatesKico Knee Innovation’s ARVIS Surgical Navigation System Gen 2 (model/catalog IN-29200) running ARVIS Hip and Knee Gap Balance Software v3.3.2 or ARVIS Shoulder Software v2.0.3 is affected; devices are identified by the model and software versions listed in the recall. The firm recalled the systems because an internal sensor issue can cause the image displayed in the eyepiece to appear tilted relative to the eyepiece housing.
What's being recalled
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…
Recalling firm: Kico Knee Innovation Company, Pymble, Australia.
How to identify it
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
The hazard
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Consignee Consignee Number Region Device Quantity RFK MEDICAL CE102 RICHMOND VA IN-29200, ARVIS SURGICAL NAVIGATION 1 VALOR MEDICAL CE118 SAN ANTONIO TX IN-29200, ARVIS SURGICAL NAVIGATION 2 JOINT VENTURES MEDICAL CE121 OSHKOSH WI IN-29200, ARVIS SURGICAL NAVIGATION 1 CASTLE MEDICAL CE122 WATERLOO IA IN-29200, ARVIS SURGICAL NAVIGATION 6 GREAT LAKES MEDICAL GL108 NAPERVILLE IL IN-29200, ARVIS SURGICAL NAVIGATION 2 CERTUS MEDICAL GL112 INDIANAPOLIS IN IN-29200, ARVIS SURGICAL NAVIGATION 5 I&S MEDICAL GL113 LOUISVILLE KY IN-29200, ARVIS SURGICAL NAVIGATION 2 PROCORE MEDICAL MA102 PIEDMONT SC IN-29200, ARVIS SURGICAL NAVIGATION 1 FOX MEDTECH MW001 ENGLEWOOD CO IN-29200, ARVIS SURGICAL NAVIGATION 2 MEDSOURCE NE131 TIVERTON RI IN-29200, ARVIS SURGICAL NAVIGATION 4 IMPLANT MEDICAL SALES NE190 HICKSVILLE NY IN-29200, ARVIS SURGICAL NAVIGATION 2 KINETIC MEDICINE NW105 OMAHA NE IN-29200, ARVIS SURGICAL NAVIGATION 4 CALSURG NW115 SANTA BARBARA CA IN-29200, ARVIS SURGICAL NAVIGATION 4 MIDWEST MEDICAL RESOURCES SC181 OVERLAND PARK KS IN-29200, ARVIS SURGICAL NAVIGATION 3 ORTHO & SURGICAL SOLUTIONS SE175 GUAYNABO PR IN-29200, ARVIS SURGICAL NAVIGATION 3 JOINT MEDICAL SOLUTIONS SE180 BIRMINGHAM AL IN-29200, ARVIS SURGICAL NAVIGATION 4 FLT ORTHOPEDICS SE216 TAMPA FL IN-29200, ARVIS SURGICAL NAVIGATION 6 MAC MEDICAL W180 GILBERT AZ IN-29200, ARVIS SURGICAL NAVIGATION 1 CP ORTHO W214 HONOLULU HI IN-29200, ARVIS SURGICAL NAVIGATION 1 UNIFIED ORTHOPEDICS W223 RIVERSIDE CA IN-29200, ARVIS SURGICAL NAVIGATION 18 MOVEMENT MEDICAL W225 SEATTLE WA IN-29200, ARVIS SURGICAL NAVIGATION 6 Total number of devices in the field 78
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)