Exactech, Inc. — 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 L
⚠️ Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- August 15, 2025
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.
What's affected?
- 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)
- Brand
- Exactech, Inc.
- Lot code
- All Serial Numbers, REF: 322-38-00/UDI:10885862593832, REF: 322-38-03/UDI:10885862593849, REF: 322-42-00/UDI: 10885862593917, REF:322-42-03/UDI:10885862593924
Additional details
All Serial Numbers, REF: 322-38-00/UDI:10885862593832, REF: 322-38-03/UDI:10885862593849, REF: 322-42-00/UDI: 10885862593917, REF:322-42-03/UDI:10885862593924
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 11,542 units.
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