Howmedica Osteonics Corp. 2025-12-31 Health serious FDA
Health · FDA · Recall #FDA-Z-0963-2026
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed… Recall
Issued December 31, 2025 · Howmedica Osteonics Corp.
In December 2025, Howmedica Osteonics Corp. recalled the The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Howmedica Osteonics Corp. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Howmedica Osteonics Corp.
- Category
- Health
- Recall date
- December 31, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.
- Recall number
- FDA-Z-0963-2026
- Made in
- United States
- Issuing agency
- FDA
In context
- Howmedica Osteonics Corp. has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.