The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit boar
Pending LLM rewrite. Source: FDA_DEVICE Z-0963-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- 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 positio
- Manufacturer
- Howmedica Osteonics Corp.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Part Number: 6000-390-000
- UDI-DI: 37613327097628
- Lots: 6000106885
- 6000106894
- 6000106895
- 6000106896
Distribution
Distributed nationwide across the United States.
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