FDA recall Z-1857-2025

Onkos Surgical, Inc. · Class II · device

Product

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

Reason for recall

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

Distribution

US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.

Key facts

Status
Ongoing
Initiation date
2024-09-22
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Parsippany, NJ, United States

Primary source

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