stryker HoloBlueprint Application — Class II medical device recall Z-1542-2025
Ongoing recall by Tornier S.A.S., reported 2025-04-16, distributed in AK, ID, MA, MN, PA, TN, TX. Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidan
| Recall number | Z-1542-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier S.A.S., Montbonnot-Saint-Martin, N/A, France |
| Recall initiated | 2025-03-05 |
| Classified | 2025-04-08 |
| Reported by FDA | 2025-04-16 |
| Distributed | AK, ID, MA, MN, PA, TN, TX |
| Countries outside the US | CA, FR, IE |
| Quantity | 14 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 03700434016505 |
| Model numbers | MRUE001 |
Product
stryker HoloBlueprint Application, Catalog Number MRUE001; 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.
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-1542-2025. 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.