The Stryker CranialMask Tracker is a single-use device consisting of… — Class II medical device recall Z-0963-2026
Ongoing recall by Howmedica Osteonics Corp., reported 2025-12-31, distributed nationwide. When the device is activated during surgery, the device software issues an error message "Instrument Face Mask
| Recall number | Z-0963-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2025-11-12 |
| Classified | 2025-12-19 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, DE, JP, KR |
| Quantity | 320 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 37613327097628 |
| Lot numbers | 6000106885, 6000106894, 6000106895, 6000106896 |
| Model numbers | 6000-390-000 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0963-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.