Howmedica Osteonics Corp.: Medical Device Recall in 2025 - (Recall #: Z-0963-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: November 12, 2025

Date Posted: December 31, 2025

Recall Number: Z-0963-2026

Event ID: 97988

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.

Status: Ongoing

Product Quantity: 320 units

Code Information:

Part Number: 6000-390-000; UDI-DI: 37613327097628; Lots: 6000106885, 6000106894, 6000106895, 6000106896;

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated