Medical device recalls Moderate risk

Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

Recall date
September 22, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1857-2025
FDA classification
Class II
Brand / firm
Onkos Surgical, Inc.
Sold / distributed
US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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