Recall Z-0963-2026 ยท HAW Neurological Stereotaxic Instrument
Howmedica Osteonics Corp.
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
| Date | Dec 19, 2025 (initiated Nov 12, 2025) |
| Status | Open, Classified |
| Reason | 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 | Under Investigation by firm |
| Action | 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. Complet |
| Quantity | 320 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Na Stryker Corporation, Feb 16, 2023 |