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Devices
Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0
Model / Serial
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.
Product Classification
Neurological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide distribution: USA, Australia, Austria, Belgium, Canada, France, Germany, Italy, Singapore, South Africa, Switzerland and United Kingdom.
Product Description
Orthosoft Navitrack, OS Unicondylar Knee 1.0 - Universal; software application for orthopedic surgical stereotaxic instrument.
Manufacturer
Zimmer Inc.
1 Event
Recall of Device Recall Orthosoft Navitrack, OS Unicondylar Knee 1.0
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Manufacturer
Zimmer Inc.
Manufacturer Address
Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
Source
USFDA
Language
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