Intellijoint Surgical, Inc. recalls Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation…

Recall date

February 11, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1559-2020

FDA classification

Class II

Brand / firm

Intellijoint Surgical, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.

Why it was recalled

During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.