Recall Z-0587-2024— Exactech, Inc.

Name: FDA recall Z-0587-2024
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 one FDA 510(k) clearance: K152217. Product: Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03. 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

1 on FDA's record

K152217 — Exactech Vantage Total Ankle SystemExactech, Inc.·cleared 2016-03-10

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 Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03

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.