Recall Z-0906-2015— Exactech, Inc.

Name: FDA recall Z-0906-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-09

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2014-10-09, terminated 2016-06-08. It names one FDA 510(k) clearance: K033883. Product: Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants. Reason: Mislabeled.

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-09
Terminated: 2016-06-08
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K033883 — OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABIExactech, Inc.·cleared 2004-02-13

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

Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03. Usage:Femoral implants

Reason for recall

Mislabeled

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