Quick Facts at a Glance
- Recall Date
- August 15, 2025
- Hazard Level
- HIGH
- Brand
- Exactech
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
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: 320-38-00, REF: 320-38-03, REF: 320-42-00, REF: 320-42-03
- Sizes
- 38mm, 42mm
- Sold at
- Multiple Retailers
- 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 Equinoxe reverse shoulder system uses humeral liners to articulate with the glenoid component in shoulder arthroplasty. These parts are implanted by surgeons and managed within clinical care settings.
Why This Is Dangerous
The liner’s articular surface position is outside the dimensional specification in labeling, which could impact implant performance.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers and patients may require medical follow-up or revision surgery. The recall emphasizes immediate action to stop use.
Practical Guidance
How to identify if yours is affected
- Compare these REF numbers to your surgical implant records
- Review the recall notice and email communications from Exactech
- Consult your surgeon for next steps
Where to find product info
Check labeling on the device packaging and surgical records for REF numbers; hospital inventory and implant logs also list model numbers
What timeline to expect
Timeline for remediation is not specified; coordination with healthcare provider will determine the process and scheduling, typically weeks to months
If the manufacturer is unresponsive
- Escalate with your surgeon or hospital implant coordinator
- Contact Exactech recall team via official channels for guidance
- File a patient safety report with the hospital if guidance is not provided promptly
How to prevent similar issues
- Verify device model numbers before implantation and maintain detailed implant records
- Ask surgeons about labeling specifications and recall status for implants
- When purchasing implants, ensure the device is the correct specification and that recall status is checked
Documentation advice
Keep copies of the recall notice, emails from Exactech, surgeon communications, and any imaging or revision records
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Product Details
Product: Exactech Equinoxe reverse shoulder humeral liners REF numbers: 320-38-00, 320-38-03, 320-42-00, 320-42-03 Quantity recalled: 61,334 units Distribution: Worldwide; U.S. states listed include 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; countries include 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 date: 2025-08-15 Status: ACTIVE
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Global distribution with U.S. state and international coverage
- Articular surface misalignment relative to labeling specifications
- Recall issued 2025-08-15; active as of 2025-09-24
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Safety Guide
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