CanadaCranialMask Tracker units (model/catalogue number 6000-390-000) with serial/lot numbers 6000106896, 6000106885, and 6000106894 are affected; the issue appears when the device is activated during surgery. Stryker identified that the Cranial Guidance Software may display the error message: "Instrument 'Face Mask (6001385000000) is not valid for this application." Contact the manufacturer, Stryker Leibinger GmbH & Co. KG, for additional information.
What's being recalled
Companies: Stryker Leibinger Gmbh & Co. Kg, Botzinger Strasse 41, Freiburg, Germany, 79111.
How to identify it
Affected products: CranialMask Tracker; Lot or serial number: 6000106896; Model or catalogue number: 6000-390-000
Affected products: CranialMask Tracker; Lot or serial number: 6000106885; Model or catalogue number: 6000-390-000
Affected products: CranialMask Tracker; Lot or serial number: 6000106894; Model or catalogue number: 6000-390-000
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)