FDA Device recall Z-0846-2025
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200
- FDA Device
- Class II
- ongoing
- Published 2025-01-22
On 2025-01-22 the FDA classified a Class II recall of Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200 by Tornier S, citing 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 P….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0846-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tornier S |
| Distribution | AK, ID, KY, MA, MD, MN, TX |
Product
Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide, REF MRUE200. Indicated for use during Total Shoulder Arthroplasty.
Reason
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.
Identifiers
| code_info | UDI/DI 03700434022926, Lot Numbers: 22A796, 22A797, 22A978, and 22A979 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0846-2025%22
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