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.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
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
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.
The reverse shoulder humeral liners have an incorrect articular surface position, which may lead to serious complications for patients. This recall falls under Class II, indicating a high risk of injury.
Currently, there are no reported injuries or incidents directly linked to this defect. The recall is a precautionary measure.
Patients and healthcare providers should stop using these liners immediately. Contact Exactech, Inc. or your healthcare provider for further instructions.
For more information, visit Exactech's website or contact them via email. Additional details are available at the FDA's recall page.
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Labeling: Incorrect or Missing Lot and/or Exp Date
Labeling: Incorrect or Missing Lot and/or Exp Date
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.