Howmedica Osteonics Corp. recalls The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 inf…

Recall date

November 12, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0963-2026

FDA classification

Class II

Brand / firm

Howmedica Osteonics Corp.

Sold / distributed

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

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.