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Health Canada Medical devices

Equinoxe® Reverse Shoulder System - Humeral Liner

Issued August 29, 2025
Issue
Exactech is recalling Equinoxe® humeral liners due to non-conformance identified during inspection at Exactech's Sarasota facility for liners as they were found to have spherical articular surface positioned out of specification relative to the engineering drawing. A manufacturing non-conformance has been identified during inspection of Equinoxe® humeral liners. Specifically, the spherical articular surface of certain liners may be positioned outside of specified tolerances, which could adversely affect joint alignment and overall implant performance. Recall start date: August 15, 2025
Hazard description
Performance
Product
Product name
Equinoxe® Reverse Shoulder System - Humeral Liner
Reference
ID
RA-77999