PlainRecordsELEOS MALE-FEMALE MIDSECTION 40MM…
- Reason
- Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Status
- Ongoing
- Distribution
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
- Enforcement report date
- June 4, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Onkos Surgical, Inc.
- Product
- ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Reason
- Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
- Distribution pattern
- US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
- Quantity
- 24 units
- Codes and lots
- Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
- Recall started
- Sept. 22, 2024
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Root cause (FDA)
- Nonconforming Material/Component
- What the company told customers
- 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.
- Recall number
- Z-1857-2025
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.”ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System, FDA enforcement report, 2025-06-04. The caption is the record's own words.
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FDA device name: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Distributed in (FDA's record): Arizona California Florida Maryland Missouri North Carolina Tennessee and nationwide
This recall among the others
- FDA's enforcement report came 255 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1857-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1857-2025, June 4, 2025. "ELEOS MALE-FEMALE MIDSECTION 40MM." PlainRecords, https://plainrecords.com/recall/device/z-1857-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections