Recall Z-2957-2026
Kico Knee Innovation Company · initiated July 13, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: 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
Reason for recall
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
FDA-determined cause: Device Design
Action taken
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. Customers are instructed to: 1. Do not use the ARVIS Gen 2 Navigation System for any hip procedures. 2. 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. 3. 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. 4. This notice must be physically posted on or near all ARVIS Gen 2 Navigation Systems. 5. Retain a copy of this letter, place a copy where devices are stored, and keep a copy of the acknowledgement form for your files. 6. Complete the attached Acknowledgement Form immediately and return it email to Alexander.Borchardt@enovis.com 7. The ARVIS Gen 2 Navigation System should always be visually inspected prior to use as stated in the Instructions for Use. 8. Inform KICO of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process. For question - contact either Sr Product Manager at Jamie.reynolds@enovis.com (512) 451-3815 or Sr Director, Regulatory Affairs at Sherri.Mellingen@enovis.com (952) 913-6383
Details
- Recall number
- Z-2957-2026
- Initiated
- July 13, 2026
- Posted by FDA
- August 14, 2026
- Product code
- SBF – Orthopedic Augmented Reality
- Quantity
- 78
- Distribution
- 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…
- Recalling firm
- Kico Knee Innovation Company, Pymble