Exactech recalled 61,334 units of Reverse Shoulder Humeral Liners on August 15, 2025. The liners do not meet specified dimensional standards, posing a risk to patients. Healthcare providers and patients must stop using the devices immediately.
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 affects Exactech Reverse Shoulder Humeral Liners, including all serial numbers. The models include REF: 320-38-00, REF: 320-38-03, REF: 320-42-00, and REF: 320-42-03. These products were distributed worldwide, including in the United States.
The recalled humeral liners have an articular surface position outside of the specified dimensional standards. This defect may lead to complications during surgery or recovery.
There are no specific incident reports or injuries associated with this recall at this time. The risk level is categorized as high due to potential complications.
Patients and healthcare providers should stop using these devices immediately. Contact Exactech, Inc. or your healthcare provider for further instructions and recall details.
For more information, visit Exactech's website or contact them via email. For additional resources, refer to 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.