Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0...
FDA Recall #Z-2561-2025 — Class II — August 15, 2025
Product Description
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE 38MM HUM LINER +2.5/ 320-42-00,145-DEG PE 42MM HUM LINER +0/ 320-42-03,145-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.
Recalling Firm
Exactech, Inc. — Gainesville, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
61,334 UNITS
Distribution
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.
Code Information
All Serial Numbers, REF: 320-38-00/UDI:10885862086655 REF: 320-38-03/UDI: 10885862086662 REF: 320-42-00/UDI: 10885862086693 REF: 320-42-03/UDI: 10885862086709
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated