Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
The Stryker CranialMask Tracker is a single-use device consisting of Recalled by Howmedica Osteonics Corp. Due to When the device is activated during surgery, the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Howmedica Osteonics Corp. directly.
Affected 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.
Quantity: 320 units
Why Was This 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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Howmedica Osteonics Corp.
Howmedica Osteonics Corp. has 229 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report