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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Intellijoint Surgical, Inc.
- Reason for Recall:
- During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
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.
Product Codes/Lot Numbers:
Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1559-2020
Related Recalls
Workstation, G2, Configured (P/N 000-0241)
Intellijoint Surgical
Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.