Device 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.
Z-1559-2020
Product summary
- Event
- Event 85016
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
device-enforcement:Z-1559-2020
Official wording
Reason: During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Code information: Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
Derived failure modes
-
Device software or design
software may