Tornier S.A.S.: Medical Device Recall in 2025 - (Recall #: Z-1535-2025)

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:

stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, packaged in stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

Product Classification:

Class II

Date Initiated: March 5, 2025

Date Posted: April 16, 2025

Recall Number: Z-1535-2025

Event ID: 96437

Reason for Recall:

Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is multifactorial, but in each instance prohibits the system from meeting its intended use. The most commonly reported complaints were related to impaired software functioning, impaired instrumentation functioning, and general difficulties using the product.

Status: Ongoing

Product Quantity: 22 units

Code Information:

All lots manufactured through Oct 2024, Distributed 23-Aug-2023 through 31-Dec-2024, GTIN 03700434022933

Distribution Pattern:

US: TX, MN, AK, PA, MA, TN, ID, and France, Canada, and Ireland

Voluntary or Mandated:

Voluntary: Firm initiated