Howmedica Osteonics Corp.: Device Recall

Recall Details

Recall Number

Z-0963-2026

Classification

Class II

Product Type

Device

Recalling Firm

Howmedica Osteonics Corp.

Status

Ongoing

Date Initiated

11/12/2025

Location

Mahwah, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

320 units

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.

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.

Distribution Pattern

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

Other Recalls by Howmedica Osteonics Corp.

• Class II: Risk 08/28/2025
  a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
• Class II: Risk 09/04/2024
  Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
• Class II: Risk 08/07/2024
  Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
• Class II: Risk 08/05/2024
  A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
• Class II: Risk 06/19/2024
  Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the 38mm)

View all recalls by Howmedica Osteonics Corp. →