Howmedica recalls Stryker CranialMask Tracker devices that cause software errors during surgery, preventing proper use. Affected units have specific part numbers and lots.
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.
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.
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.
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.
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.
Verify if the device displays the error message "Instrument Face Mask (6000-390-000) is not valid for this application" when activated during surgery.
The device displays an error message when activated during surgery, preventing it from being used correctly.
Part number 6000-390-000 with lots 6000106885, 6000106894, 6000106895, and 6000106896.
The recall record does not mention a remedy or fix for the software error.
We’ve drafted a message you can send Howmedica to request your refund or repair — edit it as you like.
Subject: Recall Z-0963-2026 — Howmedica Howmedica Hello, I own a Howmedica that is covered by recall Z-0963-2026 from Howmedica. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
