Z-1738-2025Class II

Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement

Name: Z-1738-2025 Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement
Creator: Tornier S.A.S.
Published: 2025-04-10
License: https://open.fda.gov/license/

Tornier S.A.S. / initiated 2025-04-10 / Open, Classified / root cause: software

FDA source

Tornier S.A.S. began a recall of Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement on 2025-04-10. FDA classified it as Class II and gives the reason as "A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1738-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-10
Posted: 2025-05-08
Recalling firm: Tornier S.A.S.
Product: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
Root cause tag: software
FDA 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 when it is available.
Quantity in commerce: 438 users
Distribution: Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Product codes and lots: Software Version 4.2.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1738-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-14	2025-05-08

Product code PHX

K211359Class IITornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific InstrumentationTornier, Inc. / cleared 2021-11-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)