Device product
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
Z-1857-2025
Product summary
- Event
- Event 96780
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-1857-2025
Official wording
Reason: Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.
Code information: Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Derived failure modes
-
Unknown
Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.