Health product recall

Equinoxe® Reverse Shoulder System - Humeral Liner

Brand(s)
Last updated

Summary

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

Affected 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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Orthopaedics
Companies

Exactech Inc.

2320 Nw 66th Court, Gainesville, Florida, United States, 32653

Published by
Health Canada
Audience
Healthcare
Industry
Recall class
Type II
Identification number
RA-77999

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