HIGH

Exactech Recalls Reverse Shoulder Humeral Liners Over Hazard

Exactech recalled 11,542 reverse shoulder humeral liners on August 15, 2025. The devices have an articular surface position outside of the specified dimensions. This recall affects units distributed worldwide, including several U.S. states.

Quick Facts at a Glance

Recall Date
August 15, 2025
Hazard Level
HIGH
Brand
Exactech
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Exactech, Inc. or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recall includes Exactech Equinoxe Reverse Shoulder Humeral Liners with model references 322-38-00, 322-38-03, 322-42-00, and 322-42-03. These liners were distributed in various countries, including Australia, Canada, and the United Kingdom.

Key Facts

  • Recall date: August 15, 2025
  • Quantity recalled: 11,542 units
  • Distribution: Worldwide including U.S. states and multiple countries
  • Hazard classification: Class II

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeReverse Shoulder Humeral Liners
Sold At
Multiple Retailers

Product Details

Model Numbers
REF: 322-38-00/UDI:10885862593832
REF: 322-38-03/UDI:10885862593849
REF: 322-42-00/UDI: 10885862593917
REF:322-42-03/UDI:10885862593924
Affected States
ALL
Report Date
September 24, 2025
Recall Status
ACTIVE

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