Recall Z-0953-2013— Exactech, Inc.

Name: FDA recall Z-0953-2013
Creator: U.S. Food and Drug Administration
Published: 2013-02-01

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2013-02-01, terminated 2014-09-22. It names one FDA 510(k) clearance: K071738. Product: Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.. Reason: A dimensional mismatch was identified which can potentially allow for interference between devices..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-02-01
Terminated: 2014-09-22
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K071738 — EXACTECH OPTETRAK PROXIMAL TIBIAL SPACERExactech, Inc.·cleared 2007-08-15

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 Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.

Reason for recall

A dimensional mismatch was identified which can potentially allow for interference between devices.

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