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U.S. Department of Health and Human Services

Class 2 Device Recall ELEOS LIMB SALVAGE SYSTEM

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  Class 2 Device Recall ELEOS LIMB SALVAGE SYSTEM see related information
Date Initiated by Firm May 23, 2017
Create Date June 29, 2017
Recall Status1 Terminated 3 on June 27, 2018
Recall Number Z-2646-2017
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 18MM, LENGTH 120MM, STYLE STRAIGHT, TYPE CANAL FILLING, COLLAR 25MM, REF 2500SP18E
Code Information LOT 1700558
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 2		 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 and Original Applicant = Onkos Surgical, Inc.
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