Howmedica Stryker CranialMask Tracker: Software Error Prevents Device Use During Surgery
Howmedica recalls Stryker CranialMask Tracker devices that cause software errors during surgery, preventing proper use. Affected units have specific part numbers and lots.
Lower-risk 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.
Contact the company
What happened, in plain English
Howmedica is recalling Stryker CranialMask Tracker devices that malfunction during surgery by displaying an error message. This prevents the device from being used correctly, which could impact surgical procedures. Read more at govinfonow.com/recall/50668-howmedica-stryker-cranialmask-tracker-software-error-prevents-device-use-during.
Source Summary by GovInfoNow · govinfonow.com/recall/50668-howmedica-stryker-cranialmask-tracker-software-error-prevents-device-use-during · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0963-2026
Cite this page
“Howmedica Stryker CranialMask Tracker: Software Error Prevents Device Use During Surgery.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/50668-howmedica-stryker-cranialmask-tracker-software-error-prevents-device-use-during. Based on FDA recall #Z-0963-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0963-2026%22&limit=1).
Why it’s dangerous
The device displays an error message when activated during surgery, making it impossible to use. This error occurs due to a software issue with the device's unique identifier, preventing it from functioning properly in surgical settings.
Who’s affected
Surgical teams using the Stryker CranialMask Tracker during procedures are affected. The risk is low as the issue is a software error that doesn't cause physical harm.
How to tell if you have this one
Check for part number 6000-390-000 and lots 6000106885, 6000106894, 6000106895, or 6000106896. The device is sold as a single-use surgical tracking tool.
- Brand
Howmedica- Category
Medical device
What to do — step by step
Check Device Status
Verify if the device displays the error message "Instrument Face Mask (6000-390-000) is not valid for this application" when activated during surgery.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 49 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0963-2026 (November 12, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0963-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.