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Intellijoint Surgical, Inc. recalls Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation S
Recalled April 1, 2020 · FDA recall Z-1559-2020 · Intellijoint Surgical
Hazard
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth. · FDA Class II
Units
N/A
Sold at
Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
Description
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Product
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.
Manufacturer(s)
Intellijoint Surgical, Inc.
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →