Stryker recalled 320 units of the CranialMask Tracker on November 12, 2025, due to software errors during surgery. The device fails to activate properly, displaying an error message that prevents its use. Healthcare providers must stop using this device and follow recall instructions immediately.
When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this application" resulting in an inability to use the device.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Howmedica Osteonics Corp. or your healthcare provider for instructions. Notification method: Letter
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The recalled product is the Stryker CranialMask Tracker, Part Number 6000-390-000. It is a single-use surgical device with an electronics control unit and infrared LEDs. The devices were distributed worldwide, including the US, Canada, Germany, Japan, and South Korea.
The device software issues an error message when activated, stating "Instrument Face Mask (6001385000000) is not valid for this application." This error prevents the device from being used during surgery, potentially impacting patient care.
No specific injuries or incidents have been reported in connection with this recall. However, the inability to use the device during surgery poses a high risk to patient safety.
Healthcare providers and patients should cease using the CranialMask Tracker immediately. Follow the recall instructions provided by the manufacturer and contact Howmedica Osteonics Corp. for further guidance.
For more information, call Howmedica Osteonics Corp. directly or visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0963-2026.
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