ARVIS Surgical Navigation System Gen 2
Kico Knee recalls ARVIS Surgical Navigation System Gen 2 over tilted eyepiece image from sensor issue.
Contact Kico Knee Innovation to arrange for a software update or corrective action to address the sensor issue. Do not rely solely on the augmented reality display for positional or alignment information during surgery.
Why it was recalled
Kico Knee Innovation is recalling the ARVIS Surgical Navigation System Gen 2 (Model IN-29200) because an internal sensor issue may cause the image displayed in the eyepiece to appear tilted relative to the eyepiece housing. The recall affects the ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) and ARVIS Shoulder Software v2.0.3 (IN-23630).
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
Kico Knee Innovation ARVIS SURGICAL NAVIGATION SYSTEM GEN 2Model/Catalog number: IN-29200Software version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630)
| Lot code | UDI-DI |
|---|---|
| – | 00810180351287 |
| 45200 | 00810180351287, v3.3.2, IN-28200, v2.0.3, IN-23630 |
Where it was sold
Distributed in Alabama, Arizona, California, Colorado, Florida, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Missouri, North Dakota, Nebraska, New York, Ohio, Rhode Island, South Carolina, South Dakota, Texas, Virginia, Washington, and Wisconsin.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Device Defect recalls
Other recent recalls from Kico Knee Innovation Company
Editorial summary by Recall Canary · summary updated 2026-08-16 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification