Stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide — Class II medical device recall Z-0846-2025
Ongoing recall by Tornier S.A.S., reported 2025-01-22, distributed in AK, ID, KY, MA, MD, MN, TX. The Pin Guide is being recalled because the metal tube may disassemble from the plastic handle. This can resul
| Recall number | Z-0846-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier S.A.S., Montbonnot-Saint-Martin, France |
| Recall initiated | 2024-12-18 |
| Classified | 2025-01-10 |
| Reported by FDA | 2025-01-22 |
| Distributed | AK, ID, KY, MA, MD, MN, TX |
| Countries outside the US | CA, FR |
| Quantity | 24 units |
| UPC / GTIN / UDI-DI | 03700434022926 |
| Lot numbers | 22A796, 22A797, 22A978, 22A979 |
| Model numbers | MRUE200 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0846-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.