Exactech recalled 11,542 Equinoxe reverse shoulder humeral liners worldwide after finding the articular surface position outside labeling specifications. The recall covers several REF numbers and UDIs and is active as of 2025. Healthcare providers were advised to stop using affected liners and follow manufacturer instructions.
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 Exactech Equinoxe system is a shoulder arthroplasty product used to replace damaged shoulder joints. Liners are a critical component affecting articulation and joint stability.
Dimensional nonconformity of the articular surface could affect joint function and wear patterns, potentially leading to complications.
This recall is part of a broader pattern of precision-dimension issues in orthopedic implants.
Immediate device cessation required for affected patients; clinicians will determine replacement options, potential costs, and timelines.
UDI labels and labeling on the implant packaging; patient records and recall notices e-mailed by Exactech
Replacement or refund timelines vary by case and provider; coordination with surgeon and hospital required
Keep all recall notices, emails, medical records, and consent forms related to the implant
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.
No injuries or incidents have been reported in the provided data.
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