Official recall record
Equinoxe® Reverse Shoulder System - Humeral Liner
- Issuing authority
- Health Canada — Medical Devices
- Published
- 2025-08-29
- Country of alert
- Canada
- Alert level
- Type II
- Alert type
- recall
What the authority reported
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
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.