FDA Device recall Z-1738-2025
Blueprint Software, BPUE001
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of Blueprint Software, BPUE001 by Tornier S, citing A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1738-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-10 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Tornier S |
| Distribution | US |
Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Reason
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Identifiers
| code_info | Software Version 4.2.1 |
|---|
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-1738-2025%22
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