Shoulder surgical planning software recalled over possible implant malalignment risk
Kico Knee Innovation Company is recalling 21 ARVIS Shoulder systems after a complaint identified an issue with the AI surgical planning software that may cause implant malalignment.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: surgical planning that may misalign an implant is a clinical risk, and no injuries are reported.
Plain-English summary
The ARVIS Shoulder system, model IN-27300 with ARVIS Surgical Planning Software version V2025.1.2, a computer-controlled navigation system, is being recalled.
A complaint identified an issue with the AI surgical planning software that may result in implant malalignment and/or decreased range of motion.
The recall covers 21 systems, distributed in Indiana, Minnesota, Missouri, Ohio, Florida, Illinois, Rhode Island, Kentucky, California, Wisconsin, Michigan, Pennsylvania, Washington, Colorado and Alabama. The FDA has classified the action as Class II.
The enforcement record describes the planning issue and reports no injuries. Surgical teams running the affected software version should follow the firm's instructions.
The recalled product
- Product
- Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version: V2025.1.2 Product Description: Intended Use: The ARVIS" system is a computer-controlled navigation system intended to provide intra-operative mea
- Manufacturer
- Kico Knee Innovation Company
- Hazard
- software-defect
- implant-malalignment
- surgical-planning
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Software Version V2025.1.2
Distribution
Distributed nationwide across the United States.
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