Recall Z-0113-2024— Tornier, Inc

Name: FDA recall Z-0113-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-15

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2023-09-15. It names one FDA 510(k) clearance: K161742. Product: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502. Reason: One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-09-15
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K161742 — Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc.·cleared 2016-11-15

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 Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Reason for recall

One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

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