Z-0963-2026Class II

The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB)...

Name: Z-0963-2026 The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB)...
Creator: Howmedica Osteonics Corp.
Published: 2025-11-12
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2025-11-12 / Open, Classified / root cause: software

FDA source

Howmedica Osteonics Corp. began a recall of 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)... on 2025-11-12. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0963-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-12
Posted: 2025-12-19
Recalling firm: Howmedica Osteonics Corp
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.
Product code: HAW Neurological Stereotaxic Instrument
Reason for recall: 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 tag: software
FDA 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. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form with quantity of devices discarded and email to [email protected]. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
Quantity in commerce: 320 units
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Product codes and lots: Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0963-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0963-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-12-31	2025-12-19

Product code HAW

K212194Class IIStryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting SystemStryker Corporation / cleared 2023-02-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)