FDA-Device2025-12-31Class II
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.
Howmedica Osteonics Corp.
Hazard
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.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Affected count
320 units
Manufactured in
325 Corporate Dr, N/A, Mahwah, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2026Don't want to check this manually?
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