Recall Z-1208-2019— Exactech, Inc.

Name: FDA recall Z-1208-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-13

Class II · Terminated

Class II FDA medical device recall by Exactech, Inc., initiated 2019-03-13, terminated 2021-04-22. It names one FDA 510(k) clearance: K152170. Product: Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are 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: 2.5 Truliant Fit Trays were mismarked as 3.

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Terminated: 2021-04-22
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K152170 — Exactech Optetrak Logic Enhanced AssemblyExactech, Inc.·cleared 2015-09-03

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

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are 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

2.5 Truliant Fit Trays were mismarked as 3

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