FDA Device recall Z-1857-2025
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- FDA Device
- Class II
- ongoing
- Published 2025-06-04
On 2025-06-04 the FDA classified a Class II recall of ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System by Onkos Surgical, citing potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1857-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-22 |
| Published | 2025-06-04 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Onkos Surgical |
| Distribution | US |
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.
Identifiers
| code_info | Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1857-2025%22
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