Class 2 Device Recall ELEOS LIMB SALVAGE SYSTEM

• Date Initiated by Firm: May 23, 2017
• Create Date: June 29, 2017
• Recall Status: Terminated on June 27, 2018
• Recall Number: Z-2647-2017
• Recall Event ID: 77309
• 510(K)Number: K161520
• Product Classification: Prosthesis, knee, femorotibial, constrained, cemented, metal/polymer - Product Code KRO
• Product: ELEOS LIMB SALVAGE SYSTEM SEGMENTAL STEM, CANAL FILLING, DIAMETER 20MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM; REF 2500SP20E
• Code Information: LOT 1700559
• FEI Number: 3013450937
• Recalling Firm/ Manufacturer: Onkos Surgical, Inc.; 77 E Halsey Rd; Parsippany NJ 07054-3714
• Manufacturer Reason for Recall: The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
• FDA Determined Cause: Process control
• Action: On May 23, 2017 Onkos Surgical distributed Medical Device Recall notices to their customers via courier service. Customers were advised to return the affected parts within 2 business days to: Millstone Medical 8836 Polk Lane, Suite 100 Olive Branch, MS 38654 ATTN: Anwar Powell/Recalled Product (662) 892-3612 ext. 1809. Questions regarding this recall can be addressed to: Jan Triani Senior Director of Quality Assurance and Regulatory Affairs jtriani@onkossurgical.com (973) 264-5400, M-F 8:30 am - 5:00 pm.
• Quantity in Commerce: 4 units
• Distribution: AZ, IL & KS
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

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