Howmedica Osteonics Corp.: The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31 infrared (IR) light-emit
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- Company / brand
- Howmedica Osteonics Corp.
- 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 positions can be used in one of three different modes of operation: Patient tracking, Registration using surface matching, and Automatic intra-operative mask registration.
- Reason / 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
- Recall initiated
- 2025-11-12
- Code info
- Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
- Product quantity
- 320 units
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Mahwah
- State
- NJ
- Country
- United States
- Event id
- 97988
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