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 Stryker CranialMask Tracker is a surgical device used for patient tracking and mask registration during procedures. It provides essential functionality in surgical settings where precise tracking is necessary.
The device's software malfunction leads to an error message that prevents activation, which is critical during surgical operations. This can delay or compromise medical procedures.
This recall is not part of a broader industry pattern.
The recall affects surgical practices that utilize this device, potentially causing delays in procedures and necessitating alternative tracking methods.
The part number and lot number can usually be found on the packaging or the device itself.
Expect a refund or replacement process to take approximately 4-6 weeks.
Keep a record of all communications with the manufacturer and any related receipts for your records.
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.
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