Reported Aug 26, 2026 · Ongoing · Updated Sep 16, 2026
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200…
Kico Knee Innovation Company
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Kico Knee Innovation Company · Suite 3, Building 1, 20 Bridge St · Pymble
Is this the product you have?
- Brand NameKico
- Knee Innovation Product NameARVIS SURGICAL NAVIGATION
- SYSTEM GEN 2 Model/Catalog NumberIN-29200
- Software VersionARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630)
- Product DescriptionThe 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 ArthroplastyTibial 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
- ComponentNA
- Lot codes and dates
- Lot CodeGMDN - 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
76 of 76 codes
6006A11186006A1036C36006A11176006A1045C26006A11066006A11266006A11496006A1034C26006A1046C26006A1086C26006A10936006A1079C36006A1096C26006A1052C26006A1058C36006A1030C26006A10886006A1100C6006A10946006A1041C26006A1060C36006A1092C6006A11056006A11406006A1040C26006A10906006A11166006A11096006A1037C26006A1053C36006A11026006A11086006A11206006A11556006A11276006A11396006A1095C26006A11316006A11326006A11426006A11526006A11936006A11946006A12086006A12096006A11076006A1064C6006A1068C6006A1081C6006A1011C26006A11046006A11016006A1087C6006A1075C6006A1035C26006A1057C26006A1044C26006A1024C26006A1059C36006A1083C3
- Lot CodeGMDN - 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
- Amount recalled
- 78
Where it was sold
Why it was recalled
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
This product could cause temporary or reversible health problems — stop using it.
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