Exactech recalled 61,334 Equinoxe reverse shoulder humeral liners sold worldwide after finding the articular surface position outside labeling dimensions. The recall covers REF 320-38-00, REF 320-38-03, REF 320-42-00, and REF 320-42-03. Healthcare providers and patients should stop using the devices immediately and follow recall instructions distributed by email.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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
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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.
The liner’s articular surface position is outside the dimensional specification in labeling, which could impact implant performance.
This recall is not described as part of a broader industry pattern.
Consumers and patients may require medical follow-up or revision surgery. The recall emphasizes immediate action to stop use.
Check labeling on the device packaging and surgical records for REF numbers; hospital inventory and implant logs also list model numbers
Timeline for remediation is not specified; coordination with healthcare provider will determine the process and scheduling, typically weeks to months
Keep copies of the recall notice, emails from Exactech, surgeon communications, and any imaging or revision records
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
No injuries or incidents have been reported.
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