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U.S. Department of Health and Human Services

Class 2 Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0

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  Class 2 Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0 see related information
Date Initiated by Firm August 19, 2008
Date Posted March 02, 2009
Recall Status1 Terminated 3 on April 28, 2010
Recall Number Z-0985-2009
Recall Event ID 50746
510(K)Number K071714  
Product Classification orthopedic surgical stereotaxic instrument software - Product Code HAW
Product Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
Code Information 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.
Recalling Firm/
Manufacturer
Zimmer Inc.
345 E Main St
Warsaw IN 46580-2746
For Additional Information Contact
866-336-7846
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Software design
Action 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.
Quantity in Commerce 75 (34 U.S. and 41 international)
Distribution Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = ORTHOSOFT, INC.
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