🔍 RecallPedia

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

Class I - Dangerous
🏥 Medical Devices Recalled: December 22, 2023 Onkos Surgical Other Medical Devices Nationwide

What Should You Do?

  1. Check if you have this product:
    Model Number: HC-15120-03M. UDI-DI: B278HC1512003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).
  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:
Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems were mislabeled as size 13mm cemented stems.
Classification:
Class I - Dangerous

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

Status:
ongoing

Product Information

Full Description:

ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

Product Codes/Lot Numbers:

Model Number: HC-15120-03M. UDI-DI: B278HC1512003M0. Serial Numbers: P230274-1XX (XX represents 23 parts in sequential order from 101-123).

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1818-2025

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