Z-1857-2025Class II

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

Name: Z-1857-2025 ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Creator: Onkos Surgical, Inc.
Published: 2024-09-22
License: https://open.fda.gov/license/

Onkos Surgical, Inc. / initiated 2024-09-22 / Open, Classified / root cause: manufacturing process

FDA source

Onkos Surgical, Inc. began a recall of ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System on 2024-09-22. FDA classified it as Class II and gives the reason as "Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1857-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-22
Posted: 2025-05-28
Recalling firm: Onkos Surgical, Inc.
Product: ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Product code: KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.
Quantity in commerce: 24 units
Distribution: US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Product codes and lots: Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1857-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1857-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-04	2025-05-28

Product code KRO

K161520Class IIELEOS Limb Salvage SystemOnkos Surgical, Inc. / cleared 2016-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)