Class 2 Device Recall ELEOS Limb Salvage System

• Date Initiated by Firm: September 22, 2024
• Date Posted: May 28, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1857-2025
• Recall Event ID: 96780
• 510(K)Number: K161520
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System
• Code Information: Part Number: 25001040E. UDI-DI B27825001040E0. Lot Numbers: 1989873, 1989874
• FEI Number: 3013450937
• Recalling Firm/ Manufacturer: Onkos Surgical, Inc.; 77 E Halsey Rd; Parsippany NJ 07054-3714
• For Additional Information Contact: Sean Curry; 201-650-7349
• Manufacturer 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.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Onkos Medical notified consignees via email on about 09/22/2024. Consignees were instructed to segregate and quarantine any product on hand immediately, complete and return the response form, and arrange for existing implants to be returned.
• Quantity in Commerce: 24 units
• Distribution: US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = KRO