Safety Alert: Class II: Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
healthClass IIRecalled on Sep 24, 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)
🔢 11,542 units
Sold At: Exactech, Inc.(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.)
Recall #: FDA-DEVICE-Z-2562-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- 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
Get AI-Powered Summary
Premium members get instant insights to help you understand recalls faster
Instant 1-3 sentence summary
Quick action bullets
Clear guidance on what to do
Summary
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Exactech, Inc. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.