Recall MonitorHealth Products
Equinoxe® Reverse Shoulder System - Humeral Liner
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Orthopaedics
Product: Equinoxe® Reverse Shoulder System - Humeral Liner
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare, Industry
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Equinoxe® Reverse Shoulder System - Humeral Liner | More than 10 numbers, contact manufacturer. | 320-38-00 |
| Equinoxe® Reverse Shoulder System - Humeral Liner | More than 10 numbers, contact manufacturer. | 320-38-03 |
| Equinoxe® Reverse Shoulder System - Humeral Liner | More than 10 numbers, contact manufacturer. | 320-42-00 |
| Equinoxe® Reverse Shoulder System - Humeral Liner | More than 10 numbers, contact manufacturer. | 320-42-03 |
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