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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CranialMask Tracker

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 Class 2 Device Recall Stryker CranialMask Trackersee related information
Date Initiated by FirmNovember 12, 2025
Date PostedDecember 19, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0963-2026
Recall Event ID 97988
510(K)NumberK212194 
Product Classification Neurological stereotaxic Instrument - Product Code HAW
ProductThe 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.
Code Information Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;
FEI Number 3003070421
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactRachel Seligman
201-831-5000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn November 12, 2025 URGENT MEDICAL DEVICE RECALL letters were sent to customers. Actions to be taken: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware or organizations who have consigned product. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. 3. Quarantine and discontinue use of the recalled devices identified in the affected product list in Table 1. Impacted product should be discarded at the facility. 4. Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form with quantity of devices discarded and email to Stryker5235@sedgwick.com. 5. Please contact your Local Sales Office or your Stryker Sales Representative directly for product replacement and inventory questions.
Quantity in Commerce320 units
DistributionWorldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HAW
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