Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brand
- Exactech
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Exactech
- Product type
- Reverse Shoulder Humeral Liners
- Model numbers
- REF: 322-38-00, REF: 322-38-03, REF: 322-42-00, REF: 322-42-03
- Sizes
- 145-DEG 38MM, 145-DEG 42MM
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 15, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Exactech, Inc. or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The Exactech Equinoxe system is a shoulder arthroplasty product used to replace damaged shoulder joints. Liners are a critical component affecting articulation and joint stability.
Why This Is Dangerous
Dimensional nonconformity of the articular surface could affect joint function and wear patterns, potentially leading to complications.
Industry Context
This recall is part of a broader pattern of precision-dimension issues in orthopedic implants.
Real-World Impact
Immediate device cessation required for affected patients; clinicians will determine replacement options, potential costs, and timelines.
Practical Guidance
How to identify if yours is affected
- Consult surgeon to verify whether your implant is affected
Where to find product info
UDI labels and labeling on the implant packaging; patient records and recall notices e-mailed by Exactech
What timeline to expect
Replacement or refund timelines vary by case and provider; coordination with surgeon and hospital required
If the manufacturer is unresponsive
- Escalate with hospital’s risk management
- File a FDA complaint if manufacturer is unresponsive
How to prevent similar issues
- Ensure future implants use components with compliant dimensional specifications
- Routinely review manufacturer recalls for orthopedic implants
- Ask about liner tolerances and labeling during procurement
Documentation advice
Keep all recall notices, emails, medical records, and consent forms related to the implant
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Product Details
Brand: Exactech. Product: Equinoxe Reverse Shoulder Humeral Liners. Models/Refs: REF 322-38-00, REF 322-38-03, REF 322-42-00, REF 322-42-03. UDIs: 10885862593832, 10885862593849, 10885862593917, 10885862593924. Quantity: 11,542 units. Distribution: Worldwide including US states 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 countries listed in the source. Recall date: 2025-08-15. Report date: 2025-09-24. Status: Active.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- ARTICULAR SURFACE OUT OF SPECIFICATION
- Refs and UDIs listed
- Worldwide distribution including US and multiple countries
- Notification by email
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