FDA Medical Device Recalls (openFDA)
Zimmer Inc.: Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
- Recall number
- Z-0985-2009
- Recalling firm
- Zimmer Inc.
- Product
- Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
- Status
- Terminated
- Initiated
- 2008-08-19
- Posted
- 2009-03-02
- Terminated
- 2010-04-28
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K071714"]
- PMA numbers
- not on file
- Product code
- HAW
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28