United StatesThe Stryker CranialMask Tracker is a single‑use device with a flexible printed circuit board containing 31 infrared LEDs and an electronics control unit with its own battery (Part Number 6000-390-000; UDI‑DI 37613327097628; Lots 6000106885, 6000106894, 6000106895, 6000106896), distributed worldwide including the US, Canada, Germany, Japan and South Korea. It was recalled because when 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.
What's being 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.
Recalling firm: Howmedica Osteonics Corp., Mahwah, NJ, United States.
How to identify it
Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)