Recall Z-3209-2018— Exactech, Inc.

Name: FDA recall Z-3209-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-08

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2018-05-08. It names one FDA 510(k) clearance: K150890. Product: Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.. Reason: Potentially have non-conforming internal threads..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2018-05-08
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K150890 — Exactech Optetrak Logic CCExactech, Inc.·cleared 2015-05-29

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 CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Reason for recall

Potentially have non-conforming internal threads.

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