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)
Reported: September 24, 2025 Initiated: August 15, 2025 #Z-2562-2025
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)
Reason for Recall
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Details
- Recalling Firm
- Exactech, Inc.
- Units Affected
- 11,542 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.
- Location
- Gainesville, FL
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Exactech, Inc.. Units affected: 11,542 units.
Why was this product recalled? ▼
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 24, 2025. Severity: Moderate. Recall number: Z-2562-2025.
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