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Health Canada Medical devices

CranialMask Tracker

Issued November 27, 2025
Issue
Stryker has discovered an issue where the Cranial Guidance Software may generate the following error message: "Instrument 'Face Mask (6001385000000) is not valid for this application" when the CranialMask Tracker (p/n 6000-390-000) is activated during surgery.
Hazard description
Performance
Product
Product name
CranialMask Tracker
Reference
ID
RA-81286