Public recall detail

CranialMask Tracker

2025-11-27

medium
Recall Safety notice
Quick summary

Quick summary: CranialMask Tracker. Date: 2025-11-27.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: CranialMask Tracker. Date: 2025-11-27.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandStryker Leibinger Gmbh & Co. Kg
ProductCranialMask Tracker
IssueMedical devices - Performance
Recall classType II
IdentificationRA-81286

Affected products

ProductCranialMask Tracker
Lot6000106896
Model6000-390-000
Serial number6000106896
DescriptionCranialMask Tracker
ProductCranialMask Tracker
Lot6000106885
Model6000-390-000
Serial number6000106885
DescriptionCranialMask Tracker
ProductCranialMask Tracker
Lot6000106894
Model6000-390-000
Serial number6000106894
DescriptionCranialMask Tracker

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesStryker Leibinger Gmbh & Co. Kg Botzinger Strasse 41, Freiburg, Germany, 79111
Recall date2025-11-14
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-81286
Background{}
CompaniesStryker Leibinger Gmbh & Co. Kg Botzinger Strasse 41, Freiburg, Germany, 79111
AudiencesHealthcare
Source updated2025-11-27

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...