FDA Medical devices recall ·
Blueprint Software, BPUE001. Intended for use by surgeons as a pre… recall
- Recall number
- Z-1738-2025
- Date
- (initiated April 10, 2025)
- Company / brand
- Tornier S.A.S.
161 Rue Lavoisier, Montbonnot-Saint-Martin, N/A, France - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 438 users
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Why was it recalled?
A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Software Version 4.2.1
Distribution
Blueprint Version 4.2.1 is only currently available in the US. Domestic distribution nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1738-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.