🔍 RecallPedia

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

Class I - Dangerous
🏥 Medical Devices Recalled: May 20, 2025 Onkos Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223
  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:
Onkos Surgical, Inc.
Reason for Recall:
Required inspections were not performed on finished product prior to release and distribution.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

Product Codes/Lot Numbers:

Model Number: C24-0223-0003. UDI-DI #: N/A. Serial #: C24-0223

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2042-2025

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