Recall Z-1030-2017— Exactech, Inc.

Name: FDA recall Z-1030-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-07

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2016-11-07, terminated 2019-08-05. It names one FDA 510(k) clearance: K083392. Product: Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.. Reason: Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-07
Terminated: 2019-08-05
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K083392 — NOVATION 12/14 CEMENTED FEMORAL STEMSExactech, Inc.·cleared 2008-12-17

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

Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.

Reason for recall

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

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