The Stryker CranialMask Tracker is a single-use device co... (Howmedica Osteonics Corp.) – when the device is activated during s... (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting diodes (LEDs) as well as an electronics control unit for the LEDs which includes its own battery power supply. The measured LED positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
Brand
Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
Part Number: 6000-390-000, UDI-DI: 37613327097628, Lots: 6000106885, 6000106894, 6000106895, 6000106896
Products Sold
Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
Howmedica Osteonics Corp. is recalling The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit boar due to When the device is activated during surgery, the device software issues an error message "Instrument Face Mask (6001385000000) is not valid for this a. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On November 12, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list in Table 1. Impacted product should be discarded at the facility. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form with quantity of devices discarded and email to Stryker5235@sedgwick.com. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026