FDAClass IIJune 4, 2025

Eleos Male-female Midsection 40mm recall

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

Why was Eleos Male-female Midsection 40mm recalled?

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Recalling firm
Onkos Surgical, Inc.
Quantity
24 units
Distribution
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Recall date
June 4, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls