CLASS II ONGOING Device recall · Reported 4 Jun 2025 · FDA Enforcement Report
Eleos Male-female Midsection recalled by Onkos Surgical
Onkos Surgical is recalling Eleos Male-female Midsection, distributed nationwide in the US. The recall was initiated on 22 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1857-2025
- FDA event ID
- 96780
- Recalling firm
- Onkos Surgical, Parsippany, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Sep 2024
- FDA classified
- 28 May 2025
- Reported
- 4 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Sep 2024 | Recall initiated by company | |
| 28 May 2025 | Classified by FDA | +248 days |
| 4 Jun 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Where it was distributed
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Nationwide ArizonaCaliforniaFloridaMarylandMissouriNorth CarolinaTennessee
Questions about this recall
Why was it recalled?
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Which lots are affected?
Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Where was it sold?
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Onkos Surgical
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Bowed Canal Filling Stems recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System recalled by Onkos Surgical | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | Eleos Segmental Limb Salvage System, Eleos Stem Extension recalled | Onkos Surgical | Other | Nationwide |
| Device | CLASS II | My3D Personalized Solutions Humeral Cup recalled by Onkos Surgical | Onkos Surgical | Processing Deviation | Nationwide |
| Device | CLASS II | Eleos Collar Stem, Cemented, Fluted recalled by Onkos Surgical | Onkos Surgical | Labeling Errors | Nationwide |
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