Exactech, Inc. recalls Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG

Recalled September 24, 2025 · FDA recall Z-2562-2025 · Exactech

Hazard

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

Units

11,542 units

Sold at

Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MN, NV, NY, OH, OK, PR, SC, TN, TX, VA, WI and the countries of Australia, Austria, Brazil, Canada, Colombia, France, United Kingdom, Guatemala, India, Italy, Japan, Korea, Germany, The Netherlands, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Dubai.

Description

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

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)

Manufacturer(s)

Exactech, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →