Zimmer Inc. Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
All units with software versions/distribution numbers Orthosoft-unicondylar 1.0.2.31, Orthosoft-unicondylar 1.0.1.28 and Orthosoft-unicondylar 1.0.0.0.111.
Products Sold
All units with software versions/distribution numbers Orthosoft-unicondylar 1.0.2.31, Orthosoft-unicondylar 1.0.1.28 and Orthosoft-unicondylar 1.0.0.0.111.
Zimmer Inc. is recalling Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgic due to Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect parameters: If the user switches from one surgeon profile to another surgeon profile after completing anatomical landmark acquisition tasks, the application will continue to use the initial surgeon profile parameter values in the calculation of the predicted hip-knee-ankle alignment estimates, which may have different resection or component thickness parameters than are appropriate for
Recommended Action
Per FDA guidance
Zimmer notified consignees via letter dated 8/19/08, which advised them not to change the selected surgeon profile after the acquisition of landmarks has begun, and the issued will be fixed with the next software release.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026