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Cranialmask tracker

Official notice

27 Nov 2025

Last checked

27 Nov 2025

Medium riskHealth Canada

An official Health Canada notice concerns Cranialmask tracker. 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. Published 2025-11-27.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81286

Official notice

2025-11-27

The hazard

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.

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

81286

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Affected products

Product 1

Affected products - CranialMask Tracker, Lot or serial number - 6000106896, Model or catalogue number - 6000-390-000

Product 2

Affected products - CranialMask Tracker, Lot or serial number - 6000106885, Model or catalogue number - 6000-390-000

Product 3

Affected products - CranialMask Tracker, Lot or serial number - 6000106894, Model or catalogue number - 6000-390-000

Risk / hazard

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.

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Stryker Leibinger Kg, Cranialmask Tracker.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

81286

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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