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U.S. Department of Health and Human Services

Class 2 Device Recall Conformis iTotal CR G2 Knee Replacement System

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  Class 2 Device Recall Conformis iTotal CR G2 Knee Replacement System see related information
Date Initiated by Firm November 19, 2014
Date Posted December 11, 2014
Recall Status1 Terminated 3 on October 08, 2015
Recall Number Z-0581-2015
Recall Event ID 69867
510(K)Number K140423  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Conformis iTotal CR G2 Knee Replacement System
Catalog/Model #: M57250600010

Intended for use as a total knee replacement in patients with knee joint pain and disability.
Code Information Serial Number: 0340552
Recalling Firm/
Manufacturer		 ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact
781-345-9001
Manufacturer Reason
for Recall		 Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
FDA Determined
Cause 2		 Labeling mix-ups
Action Conformis notified the consignee by telephone on 11/19/14, about the problem. A sales representative visited the site and retrieved the device.
Quantity in Commerce 1 unit
Distribution Distributed to IN.
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 = CONFORMIS, INC.
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