Recall Z-1559-2020— Intellijoint Surgical, Inc.
Class II · Terminated
Class II FDA medical device recall by Intellijoint Surgical, Inc., initiated 2020-02-11, terminated 2020-06-10. It names one FDA 510(k) clearance: K191507. 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.. Reason: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth..
- Recalling firm
- Intellijoint Surgical, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-02-11
- Terminated
- 2020-06-10
- Firm location
- Waterloo, N/A, Canada
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
Reason for recall
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Data sourced from openFDA. This site is unofficial and independent of the FDA.