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Equinoxe® reverse shoulder system - humeral liner

Official notice

29 Aug 2025

Last checked

29 Aug 2025

Medium riskHealth Canada

An official Health Canada notice concerns Equinoxe® reverse shoulder system - humeral liner. 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 Published 2025-08-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

77999

Official notice

2025-08-29

The hazard

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

How to check if you're affected

Compare the product name and identifiers below with the item you own. Follow the official notice if they match.

Recall Numbers

77999

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Affected products

Product 1

Affected products - Equinoxe® Reverse Shoulder System - Humeral Liner, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 320-38-00

Product 2

Affected products - Equinoxe® Reverse Shoulder System - Humeral Liner, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 320-38-03

Product 3

Affected products - Equinoxe® Reverse Shoulder System - Humeral Liner, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 320-42-00

Product 4

Affected products - Equinoxe® Reverse Shoulder System - Humeral Liner, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - 320-42-03

Risk / hazard

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

Where it was sold

The source does not list specific retailers. See the official notice for where affected products were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Exactech, Equinoxe® Reverse Shoulder System - Humeral Liner.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

77999

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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