HIGH

Exactech Recalls Reverse Shoulder Humeral Liners Over Safety Concerns

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.

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

Product Details

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 Hazard

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.

Reported Incidents

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.

What to Do

Patients and healthcare providers should stop using these devices immediately. Contact Exactech, Inc. or your healthcare provider for further instructions and recall details.

Contact Information

For more information, visit Exactech's website or contact them via email. For additional resources, refer to the FDA's recall page.

Key Facts

  • Recall Date: August 15, 2025
  • Quantity Recalled: 61,334 units
  • Risk Level: High
  • Affected Models: All Serial Numbers
  • Distribution: Worldwide
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Safety Assessment

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

Product Classification

Product Details

Model Numbers
REF: 320-38-00
REF: 320-38-03
REF: 320-42-00
REF: 320-42-03
Affected States
ALL
Report Date
September 24, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE
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