Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instr
FDA device recall Z-0985-2009 · posted 2009-03-02 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- 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
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 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.
- Date initiated
- 2008-08-19
- Date posted
- 2009-03-02
- Date terminated
- 2010-04-28
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 (K071714) | Orthosoft, Inc. | 2007-07-20 |