Recall Z-0985-2009 ยท HAW Neurological Stereotaxic Instrument
Zimmer Inc.
Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
| Date | Mar 2, 2009 (initiated Aug 19, 2008) |
| Status | Terminated |
| Reason | 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 | 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071714 | NAVITRACK SYSTEM - OS UNICONDYLAR KNEE UNIVERSAL, MODEL# PRO-06003 Orthosoft, Inc., Jul 20, 2007 |