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U.S. Department of Health and Human Services

Class 2 Device Recall Apex Knee System

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  Class 2 Device Recall Apex Knee System see related information
Date Initiated by Firm November 20, 2017
Create Date March 19, 2018
Recall Status1 Terminated 3 on June 07, 2019
Recall Number Z-1117-2018
Recall Event ID 79268
510(K)Number K060192  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L

The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
Code Information Product Code KC-2206L, Lot # 26519
Recalling Firm/
Manufacturer		 OMNIlife science Inc.
480 Paramount Dr
Raynham MA 02767-1085
For Additional Information Contact Christina Rovaldi
508-824-2444
Manufacturer Reason
for Recall		 The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
FDA Determined
Cause 2		 Incorrect or no expiration date
Action OMNIlife science, Inc. sent an Urgent Medical Device Advisory Notice dated November 20, 2017. Actions to be taken by the Customer/User "Immediately quarantine lot 26519 for KC-2206L "Return Product Using RMA# XXXX to OMNI. "This advisory notice only includes LOT 26519. It does not affect other lots. You must acknowledge this notice by returning the attached Acknowledgement and Receipt Form and accompanying by FAX to 508-819-3390 or my email to CS@omnils.com. For further questions, please call (508) 824-2444.
Quantity in Commerce 32
Distribution Worldwide Distribution - US Distribution and to the country Spain.
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 = JWH and Original Applicant = OMNI LIFE SCIENCE, INC.
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