[pending] ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Pending LLM rewrite. Source: FDA_DEVICE Z-1857-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
The recalled product
- Product
- ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
- Manufacturer
- Onkos Surgical, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873
- 1989874
Distribution
Distributed nationwide across the United States.
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