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U.S. Department of Health and Human Services

Class 2 Device Recall Blueprint

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 Class 2 Device Recall Blueprintsee related information
Date Initiated by FirmApril 10, 2025
Date PostedMay 08, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1738-2025
Recall Event ID 96651
510(K)NumberK211359 
Product Classification shoulder prosthesis, reverse configuration - Product Code PHX
ProductBlueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Code Information Software Version 4.2.1
FEI Number 3000931034
Recalling Firm/
Manufacturer		 Tornier S.A.S.
161 Rue Lavoisier
Montbonnot-Saint-Martin France
For Additional Information Contact
+33 06 63750024
Manufacturer Reason
for Recall		A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
FDA Determined
Cause 2		Software Design Change
ActionOn 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 Commerce438 users
DistributionBlueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = PHX
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