Recall Z-1883-2024— Tornier S.A.S.

Name: FDA recall Z-1883-2024
Creator: U.S. Food and Drug Administration
Published: 2024-04-16

Class II · Ongoing

Class II FDA medical device recall by Tornier S.A.S., initiated 2024-04-16. It names one FDA 510(k) clearance: K211359. Product: Stryker Blueprint Software, Catalog #BPUE001.. Reason: The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval..

Recalling firm: Tornier S.A.S.
Classification: Class II
Status: Ongoing
Initiated: 2024-04-16
Firm location: Montbonnot St Martin, 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

Stryker Blueprint Software, Catalog #BPUE001.

Reason for recall

The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.

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