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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Implants & Prosthetics

ELEOS Midsections Recalled for Surgical Assembly Challenges

Agency Publication Date: May 28, 2025
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Summary

Onkos Surgical, Inc. has recalled 24 units of the ELEOS Male-Female Midsection (40mm), which is a key component of the ELEOS Limb Salvage System. The recall was issued because the midsection's external taper may not properly fit or assemble with the internal taper of the matching femur component during surgery. While no injuries or incidents have been reported, this mechanical challenge could occur while a patient is undergoing a procedure.

Risk

If the surgical components fail to assemble correctly during an operation, it could lead to significantly longer surgery times and extended exposure to anesthesia. In some cases, an improperly seated component might lead to the eventual mechanical failure of the implant.

What You Should Do

  1. This recall affects the ELEOS Male-Female Midsection 40mm (Part Number 25001040E) with Lot Numbers 1989873 and 1989874 and UDI-DI B27825001040E0.
  2. Stop using the recalled device immediately.
  3. Contact Onkos Surgical, Inc. or your authorized medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding medical device safety.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ELEOS Male-Female Midsection 40mm
Variants: 40mm
Model / REF:
25001040E
Lot Numbers:
1989873
1989874
UDI:
B27825001040E0

Component of ELEOS Limb Salvage System

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96780
Status: Active
Manufacturer: Onkos Surgical, Inc.
Sold By: Authorized Medical Distributors
Manufactured In: United States
Units Affected: 24 units
Distributed To: Arizona, California, Florida, Maryland, Missouri, North Carolina, Tennessee

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.