Official recall record
CranialMask Tracker
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-11-27
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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