Recall Z-1738-2025 · PHX Shoulder Prosthesis, Reverse Configuration
Tornier S.A.S.
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
| Date | May 8, 2025 (initiated Apr 10, 2025) |
| Status | Open, Classified |
| Reason | A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software. |
| Root cause | Software Design Change |
| Action | On April 10, 2025, the firm began notifying customers via Urgent Medical Device Recall letters. Customers were informed that an Online Management System (OMS) software patch was released to address the bug on March 25, 2025. The issue can no longer occur with the introduction of this patch. No actions are required on the customer's part to implement the patch. Version 4.2.2 is currently in development and is scheduled for release by end of Quarter 2, 2025. This patch will implement a permanent fix for the issue. Customers will be prompted to complete this update within the Blueprint Software |
| Quantity | 438 users |
| Distribution | Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific Instrumentation Tornier, Inc., Nov 12, 2021 |