Exactech, Inc.: Device Recall
Recall #Z-2562-2025 · 08/15/2025
Recall Details
- Recall Number
- Z-2562-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- Exactech, Inc.
- Status
- Ongoing
- Date Initiated
- 08/15/2025
- Location
- Gainesville, FL, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,542 units
Reason for Recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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)
Distribution Pattern
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.
Other Recalls by Exactech, Inc.
- Class II: Risk 09/05/2025
- Class II: Risk 09/05/2025
- Class II: Risk 09/05/2025
- Class II: Risk 08/15/2025
- Class II: Risk 12/31/2024