Company: Intellijoint Surgical, Inc.
Date of Enforcement Report: 4/1/2020
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.
- Recall Number: Z-1559-2020
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Intellijoint Surgical, Inc. on 2/11/2020. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Nationwide and International