Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Intellijoint Navigation System Recalled by Intellijoint Surgical, Inc. Due to During total knee arthroplasty (TKA), the software may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Intellijoint Surgical, Inc. directly.
Affected Products
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
Quantity: N/A
Why Was This Recalled?
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Intellijoint Surgical, Inc.
Intellijoint Surgical, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report