Recall Z-0773-2024— Tornier, Inc

Name: FDA recall Z-0773-2024
Creator: U.S. Food and Drug Administration
Published: 2024-01-03

Class II · Ongoing

Class II FDA medical device recall by Tornier, Inc, initiated 2024-01-03. It names one FDA 510(k) clearance: K183696. Product: Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.. Reason: The incorrect device is contained in the labeled package..

Recalling firm: Tornier, Inc
Classification: Class II
Status: Ongoing
Initiated: 2024-01-03
Firm location: Bloomington, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K183696 — Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc.·cleared 2019-01-30

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 Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.

Reason for recall

The incorrect device is contained in the labeled package.

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