Lower riskMedical device recall · FDA · Published September 19, 2025
ARVIS Shoulder Surgical Software V2025.1.2 Recall: Risk of Implant Misalignment
Kico Knee Innovation Company recalls ARVIS Shoulder surgical planning software version V2025.1.2 due to potential implant malalignment or reduced range of motion. Affected users should contact for remedy.
“ARVIS Shoulder Surgical Software V2025.1.2 Recall: Risk of Implant Misalignment.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51246-arvis-shoulder-surgical-software-v2025-1-2-recall-risk-of. Based on FDA recall #Z-0145-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0145-2026%22&limit=1).
The FDA announced on Sept. 19, 2025, that Kico Knee Innovation Company is recalling the ARVIS Shoulder surgical planning software (Model IN-27300) due to a potential issue with AI planning that may cause implant malalignment or decreased range of motion.
How to tell if you have it
Brand: ARVIS
Product Name: ARVIS Shoulder
Model/Catalog Number: IN-27300
Software Version: V2025.1.2
The hazard
The recall addresses a complaint regarding an issue with the AI surgical planning software that may result in implant malalignment and/or decreased range of motion.
Context
GovInfoNow's records show Kico Knee Innovation Company has issued two other recalls since April 23, 2026, including the July 13, 2026, ARVIS Surgical Navigation System Gen 2 recall for tilted images and the April 23, 2026, Arvis Hip & Knee 3.0 Instrument Set recall for wear risk. Other recent recalls of similar products include the March 19, 2026, U2 Total Knee System Femoral Offset Bushing Recall, the May 8, 2026, Think Surgical TMINI Tracking Arrays recall, and the April 20, 2026, Staar ICL Software Version 8.00 recall.
How to tell if you have this one
Check for software version V2025.1.2 on the ARVIS Shoulder system. The product was sold by Kico Knee Innovation Company for shoulder surgeries.
Brand
ARVIS
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Kico Knee Innovation Company for guidance on the recall and next steps.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 15 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY, CA, WI, MI, PA, WA, CO, AL.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Colorado, Florida, Illinois, Indiana, Kentucky, Michigan, Minnesota, Missouri, Ohio, Pennsylvania, Rhode Island, Washington, Wisconsin.
Recall timeline
FDA published this recall 33 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0145-2026 (September 19, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0145-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.