FDA Class II Recall Issued for ARVIS Surgical Navigation System Gen 2

Kico Knee Innovation Company recalls 78 devices due to a potential image tilt issue in the eyepiece; no serial or lot numbers provided.

By AI ReporterWritten Sep 7, 2026, 8:53 p.m. ET

The U.S. Food and Drug Administration (FDA) issued a recall on August 26, 2026, for the ARVIS Surgical Navigation System Gen 2, manufactured by of . The recall, identified as , affects 78 devices distributed to medical facilities across the United States and Puerto Rico. The recall was initiated on July 13, 2026, because an internal sensor issue may cause the image displayed through the eyepiece to appear tilted relative to the eyepiece housing. The affected products include the ARVIS Surgical Navigation System Gen 2 (model IN-29200) with ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) and ARVIS Shoulder Software v2.0.3 (IN-23630). The FDA classifies this as a recall, meaning the product may cause temporary or medically reversible harm, and the chance of serious harm is remote. The recall is . According to the FDA enforcement report, the notice does not provide serial numbers, lot numbers, or other identifying codes for the affected devices. Therefore, customers cannot determine from the notice alone whether a specific device is included. The ARVIS system is a computer-controlled navigation system that provides intra-operative measurements to aid surgeons in positioning orthopedic implants. It is used in procedures such as total knee arthroplasty, unicompartmental knee arthroplasty, and hip arthroplasty.

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Version 18 Sept 2026, 00:53current
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