Reported Dec 31, 2025 · Ongoing
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed circuit board (PCB) with 31…
Howmedica Osteonics Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- 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 operationPatient tracking, Registration using surface matching, and Automatic intra-operative mask registration
- Lot codes and dates
- Part Number6000-390-000
- UDI-DI37613327097628
- Lots
6000106885600010689460001068956000106896
- Amount recalled
- 320 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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