Recall Z-2957-2026 · SBF Orthopedic Augmented Reality
Kico Knee Innovation Company
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
| Date | Aug 14, 2026 (initiated Jul 13, 2026) |
| Status | Open, Classified |
| Reason | Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing |
| Root cause | 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 sens |
| 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 |
| FDA record | Open on fda.gov |