The Stryker CranialMask Tracker is a single-use device recall: Software Issue
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting…
Why was The Stryker CranialMask Tracker is a single-use device 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
- Product
- The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emitting…
- Recalling firm
- Howmedica Osteonics Corp.
- Quantity
- 320 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
- Recall date
- December 31, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)