—#76911

Product

Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K071714
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.

Timeline

Recall initiated: 2008-08-19
Posted by FDA: 2009-03-02
Terminated: 2010-04-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #76911. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.