Recall Z-0023-2022— Exactech, Inc.

Name: FDA recall Z-0023-2022
Creator: U.S. Food and Drug Administration
Published: 2021-08-30

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2021-08-30. It names 2 FDA 510(k) clearances: K171045, K152170. Product: TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.. Reason: Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-08-30
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

TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

Reason for recall

Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.

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