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

Recalling company

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.

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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Nov 12, 2025

Reported

Dec 31, 2025

Distribution

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

Status

Ongoing

Quantity

320 units

Lot / codes

Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

Company location

Mahwah, NJ

Recall type

Voluntary: Firm initiated

Recall number

Z-0963-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0963-2026 in the FDA Enforcement Report. Also see FDA recall press releases.