Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 31, 2025
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.
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 i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Howmedica Osteonics Corp. recalled The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed c… - a moderate-severity action.
The Stryker CranialMask Tracker is a single-use device consisting of a flexible printed c… was recalled by Howmedica Osteonics Corp. in December 31, 2025. Reason: When the device is activated during surgery, the device software issues an error message "Instrument Face Mas…. Check the official notice for the remedy. Verify recall #Z-0963-2026 with the FDA Devices before acting.
The recall
Howmedica Osteonics Corp. issued this moderate-severity FDA Devices recall-When the device is activated during surgery, the device software issues an error message "Instrument Face Mas….
- Moderate
- severity level
- 320 units
- affected scope
- Class II
- classification
- December 31, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0963-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0963-2026) was formally reported on December 31, 2025, with the manufacturer initiating the action on November 12, 2025. It is classified under Moderate severity (Class II), with a current status of Ongoing. Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records list the affected scope as 320 units.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
320 units
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0963-2026 |
| Date reported | December 31, 2025 |
| Date initiated | November 12, 2025 |
| Recalling firm | Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 320 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0963-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Howmedica Osteonics Corp.. Units affected: 320 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 31, 2025. Severity: Moderate. Recall number: Z-0963-2026.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0963-2026) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 31, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.