Company: Howmedica Osteonics Corp.
Date of Enforcement Report: 12/19/2025
Class: II

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

Recall Number:

Z-0963-2026

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.

RECALLING FIRM/MANUFACTURER:

Howmedica Osteonics Corp.

VOLUME:

320 units

DISTRIBUTION:

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