PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: December 31, 2025 Initiated: November 12, 2025 #Z-0963-2026

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.

Details

Recalling Firm
Howmedica Osteonics Corp.
Units Affected
320 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Location
Mahwah, NJ

Frequently Asked Questions

What product 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.. Recalled by Howmedica Osteonics Corp.. Units affected: 320 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0963-2026.

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