Recall Z-0460-2021— Exactech, Inc.

Name: FDA recall Z-0460-2021
Creator: U.S. Food and Drug Administration
Published: 2020-10-06

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2020-10-06, terminated 2023-11-13. It names one FDA 510(k) clearance: K113309. Product: Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium. Reason: The product may be mislabeled..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-10-06
Terminated: 2023-11-13
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K113309 — EXACTECH EQUINOXE CAGE GLENOIDSExactech, Inc.·cleared 2011-12-08

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

Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

Reason for recall

The product may be mislabeled.

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