# FDA recall Z-1541-2025

> **Tornier S.A.S.** · Class II · device recall initiated 2025-03-05.

## Product

stryker Blueprint Mixed Reality Instrument Kit, Catalog Number MRUEGLN; Total Shoulder Arthroplasty

## 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.

## Distribution

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

## Key facts

- **Recall number:** Z-1541-2025
- **Recalling firm:** Tornier S.A.S.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-05
- **Report date:** 2025-04-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Montbonnot-Saint-Martin, N/A, France

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1541-2025

## Citation

> AI Analytics. FDA recall Z-1541-2025. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1541-2025. Source: US FDA. Licensed CC0.

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