The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit b...
FDA Recall #Z-0963-2026 — Class II — November 12, 2025
Product Description
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 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.
Recalling Firm
Howmedica Osteonics Corp. — Mahwah, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
320 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Code Information
Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated