Recall Z-2562-2025— Exactech, Inc.

Name: FDA recall Z-2562-2025
Creator: U.S. Food and Drug Administration
Published: 2025-08-15

Class II · Ongoing

Class II FDA medical device recall by Exactech, Inc., initiated 2025-08-15. It names one FDA 510(k) clearance: K223833. Product: Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5). Reason: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling..

Recalling firm: Exactech, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-08-15
Firm location: Gainesville, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K223833 — Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysExactech, Inc.·cleared 2023-09-14

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, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

Reason for recall

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

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