Recall Z-1459-2015— Exactech, Inc.

Name: FDA recall Z-1459-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-13

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2015-02-13, terminated 2016-09-29. It names one FDA 510(k) clearance: K042021. Product: Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.. Reason: Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-02-13
Terminated: 2016-09-29
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K042021 — EXACTECH EQUINOXE SHOULDER SYSTEMExactech, Inc.·cleared 2004-10-26

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

Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.

Reason for recall

Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.

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