FDA Medical Device Recalls (openFDA)
Tornier S.A.S.: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
- Recall number
- Z-1738-2025
- Recalling firm
- Tornier S.A.S.
- Product
- Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
- Status
- Open, Classified
- Initiated
- 2025-04-10
- Posted
- 2025-05-08
- Terminated
- not on file
- 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 when it is available.
- Quantity
- 438 users
- Distribution
- Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
- Lot, serial or model codes
- Software Version 4.2.1
- 510(k) numbers
- ["K211359"]
- PMA numbers
- not on file
- Product code
- PHX
- Firm FEI
- 3000931034
- Firm city
- Montbonnot-Saint-Martin
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28