—#217390

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K212194
Affected lot / code info: Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.

Timeline

Recall initiated: 2025-11-12
Posted by FDA: 2025-12-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #217390. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.