🔍 RecallPedia

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

Class I - Dangerous
🏥 Medical Devices Recalled: August 15, 2025 Exactech Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    All Serial 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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Exactech, Inc.
Reason for Recall:
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER +2.5), REF:322-42-00 (145-DEG PE 42MM HUM LINER +0), REF: 322-42-03 (145-DEG PE 42MM HUM LINER +2.5)

Product Codes/Lot Numbers:

All Serial 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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2562-2025

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