[pending] 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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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.
Related recalls
Same category
- ModeratePhilips Allura X-ray Systems Deaeration Hose Degradation Recall
FDA (Devices) · 2026-05-27
- HighMedtronic GUNDRY Retrograde Cannula Model 94113T sterile barrier recall
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Pacing Catheter Model D200F7 Recall Due to Leak Risk
FDA (Devices) · 2026-05-27
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula 15FR Model 94665 Sterile Barrier
FDA (Devices) · 2026-05-27