# FDA recall Z-0963-2026

> **Howmedica Osteonics Corp.** · Class II · device recall initiated 2025-11-12.

## 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.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Germany, Japan, South Korea.

## Key facts

- **Recall number:** Z-0963-2026
- **Recalling firm:** Howmedica Osteonics Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-12
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mahwah, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0963-2026

## Citation

> AI Analytics. FDA recall Z-0963-2026. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-0963-2026. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*