Recall Z-0580-2024— Exactech, Inc.

Name: FDA recall Z-0580-2024
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: K212356. Product: Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35. 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

K212356 — Exactech® Equinoxe® Laser Cage GlenoidExactech, Inc.·cleared 2022-03-04

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 Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35

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.