Medical device licence · 68978 · Class 3

EQUINOXE SHOULDER SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed August 4, 2005. It is in Health Canada’s list of active licences.

Licence number: 68978
Licence holder: Exactech Inc.Gainesville, FL, United States
Risk class: Class III (moderate to high risk)
Licence type: System
First licensed: August 4, 2005
Devices covered: 20

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

EQUINOXE - ANATOMIC REPLICATOR PLATE
EQUINOXE - CTA HUMERAL HEAD
EQUINOXE - GLENOID
EQUINOXE - GLENOID - KEELED
EQUINOXE - GLENOID - PEGGED
EQUINOXE - HUMERAL HEAD
EQUINOXE - HUMERAL LONG STEM
EQUINOXE - HUMERAL LONG STEM FRACTURE, CEMENTED
EQUINOXE - HUMERAL STEM - FRACTURE
EQUINOXE - HUMERAL STEM - PRIMARY - CEMENTED
EQUINOXE - HUMERAL STEM - PRIMARY - PRESS FIT
EQUINOXE - PLASMA HUMERAL LONG STEM
EQUINOXE FIXED ANGLE REPLICATOR PLATE KIT
EQUINOXE TORQUE DEFINING SCREW
EQUINOXE TORQUE DEFINING SCREW KIT
EQUINOXE-PLATFORM FRACTURE HUMERAL LONG STEM, CEMENTED
EQUINOXE-PLATFORM FRACTURE HUMERAL STEM, CEMENTED
HUMERAL HEAD
POSTERIOR AUGMENT PEGGED GLENOID
REPLICATOR PLATE

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “equinoxe”. A notice may cover another product or only some lots: read it to see what it covers.

Equinoxe® Reverse Shoulder System - Humeral LinerAugust 29, 2025 · Orthopaedics · Performance · Type II
Equinoxe Platform Fracture Stem 6.5mm & 10.5mm, Right (2019-12-03)December 20, 2019 · Medical devices · Medical devices · Type III
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw KitDecember 13, 2016 · Medical devices · Type II
Equinoxe Humeral Head, short, 44mm (2015-02-13)March 27, 2015 · Medical devices · Health products · Type II

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.