FDAFDA · Food and drugs·Recall number Z-2562-2025
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)
Published September 24, 2025 · Recall initiated: August 15, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- 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.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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