Recall Z-1738-2025— Tornier S.A.S.

Name: FDA recall Z-1738-2025
Creator: U.S. Food and Drug Administration
Published: 2025-04-10

Class II · Ongoing

Class II FDA medical device recall by Tornier S.A.S., initiated 2025-04-10. It names one FDA 510(k) clearance: K211359. Product: Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.. Reason: A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software..

Recalling firm: Tornier S.A.S.
Classification: Class II
Status: Ongoing
Initiated: 2025-04-10
Firm location: Montbonnot-Saint-Martin, N/A, France

510(k) clearances named in this recall

1 on FDA's record

K211359 — Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient Specific InstrumentationTornier, Inc.·cleared 2021-11-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

A software bug in Blueprint version 4.2.1 prevents users from accessing cases initiated in previous versions of the software.

Data sourced from openFDA. This site is unofficial and independent of the FDA.