🔍 RecallPedia

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Class I - Dangerous
🏥 Medical Devices Recalled: September 22, 2024 Onkos Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
  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:
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Product Codes/Lot Numbers:

Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1857-2025

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