Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed…

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.

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-0963-2026
• FDA 510(k) clearance · K212194The device's official FDA premarket clearance record
• FDA device classification · HAWOfficial FDA classification for this device type
• CFR regulation · 21 CFR 882.4560The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Howmedica Osteonics Corp.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.