Recall Z-0585-2024— Exactech, Inc.

Name: FDA recall Z-0585-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-21

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2023-11-21. It names 2 FDA 510(k) clearances: K171045, K152170. Product: Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519. Reason: Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-11-21
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

2 on FDA's record

K171045 — Exactech® Truliant Line ExtensionsExactech, Inc.·cleared 2017-04-28
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

Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519

Reason for recall

Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.

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