Kico ARVIS Surgical Navigation System Gen 2: Image May Appear Tilted
Kico recalls ARVIS Surgical Navigation System Gen 2 (model IN-29200) due to potential image tilt in eyepiece. This may affect surgical alignment accuracy during procedures like knee or hip replacements.
Lower-risk recall
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
What happened, in plain English
Kico is recalling its ARVIS Surgical Navigation System Gen 2 (model IN-29200) because the image displayed through the eyepiece might appear tilted relative to the housing. This could lead to inaccurate surgical measurements during procedures like knee or hip replacements if not corrected. Read more at govinfonow.com/recall/697887-kico-arvis-surgical-navigation-system-gen-2-image-may-appear.
Source Summary by GovInfoNow · govinfonow.com/recall/697887-kico-arvis-surgical-navigation-system-gen-2-image-may-appear · Updated September 14, 2026 · FDA enforcement record: FDA #Z-2957-2026
Cite this page
“Kico ARVIS Surgical Navigation System Gen 2: Image May Appear Tilted.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697887-kico-arvis-surgical-navigation-system-gen-2-image-may-appear. Based on FDA recall #Z-2957-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2957-2026%22&limit=1).
Why it’s dangerous
The system's internal sensor issue causes the image displayed through the eyepiece to appear tilted relative to the housing. This could lead to inaccurate surgical measurements if the surgeon relies solely on the visual display without cross-referencing with other alignment tools.
Who’s affected
Surgeons using the ARVIS Surgical Navigation System Gen 2 (model IN-29200) for orthopedic procedures like knee or hip replacements are most at risk. The recall affects specific software versions and serial numbers listed in the notice.
How to tell if you have this one
Check for the model number IN-29200 on the device. The affected units have specific software versions (ARVIS Hip and Knee Gap Balance Software v3.3.2 and ARVIS Shoulder Software v2.0.3) and serial numbers listed in the recall notice.
- Brand
Kico- Category
Medical device
What to do — step by step
Check Device Model
Look for the model number IN-29200 on the device to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 16 states and Puerto Rico.
FDA 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…” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Nebraska, New York, Puerto Rico, Rhode Island, South Carolina, Texas, Virginia, Washington, Wisconsin.
Recall timeline
FDA published this recall 44 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall indicates a potential image tilt issue that could affect surgical accuracy, but the product is not unsafe to use. Surgeons should follow the manufacturer's guidance to ensure proper alignment.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2957-2026 (July 13, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2957-2026 to see it in context.
- Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.