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FDA device recallVulnerabilitiesPublished Dec 19, 2025
Howmedica Osteonics Corp.: Neurological Stereotaxic Instrument
Updated 2 hours ago ()
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
- Tags
- FDA recall, medical device, class 2, Neurology, Under Investigation by firm, Open, Classified
- Related exam domains
- CISSP 3: Security Architecture and Engineering; CISSP 8: Software Development Security
- Source record id
- Z-0963-2026
- First seen by InfoSec Signals
- Sep 23, 2026
Source: openFDA device recalls, U.S. Food and Drug Administration about this source more from it
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