Blueprint Software — Class II medical device recall Z-1738-2025
Ongoing recall by Tornier S.A.S., reported 2025-05-14, distributed nationwide. A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions o
| Recall number | Z-1738-2025 |
|---|---|
| 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 | 2025-04-10 |
| Classified | 2025-05-08 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Quantity | 438 users |
| Reason classes | software |
Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Reason for recall
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
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-1738-2025. 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.