Exactech, Inc. recalls Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibi…

Recall date

March 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1208-2019

FDA classification

Class II

Brand / firm

Exactech, Inc.

Sold / distributed

US Nationwide Distribution in the states of AR, CA, OH, OK, IN, MN, NJ, TN, SC, FL

Why it was recalled

2.5 Truliant Fit Trays were mismarked as 3

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.