# FDA recall Z-0846-2025

> **Tornier S.A.S.** · Class II · device recall initiated 2024-12-18.

## Product

Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200.    Indicated for use during Total Shoulder Arthroplasty.

## Reason for recall

The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can result in the Blueprint Mixed Reality headset being unable to detect the Pin Guide and potentially prolonging surgery time or changing of surgical method from guided to conventional.

## Distribution

US:  MN, KY, MD, MA, TX, AK, TX, ID; France, Canada

## Key facts

- **Recall number:** Z-0846-2025
- **Recalling firm:** Tornier S.A.S.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-18
- **Report date:** 2025-01-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2025

## Citation

> AI Analytics. FDA recall Z-0846-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0846-2025. Source: US FDA. Licensed CC0.

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