FDA-Device2025-06-04Class II

ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Onkos Surgical, Inc.
Hazard

Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

Sold states
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
Affected count
24 units
Manufactured in
77 E Halsey Rd, N/A, Parsippany, NJ, United States
Products
ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1857-2025

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