🔍 RecallPedia

Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

Class I - Dangerous
🏥 Medical Devices Recalled: March 22, 2024 EBI Infusion Pumps Nationwide

What Should You Do?

  1. Check if you have this product:
    UD-DI: 00812301020232 All devices distributed since May 1, 2023
  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:
EBI, LLC
Reason for Recall:
Damage to the lead wire sheath (black cable) component and causing exposure of the wires, potentially lead to no therapeutic treatment signal being delivered to the electrodes, and result in delay of treatment
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of an established nonunion acquired secondary to trauma, excluding vertebrae and all flat bones. Part Number: 1067718

Product Codes/Lot Numbers:

UD-DI: 00812301020232 All devices distributed since May 1, 2023

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1617-2024

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