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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Cruciate Retaining (CR) Knee Replacement System

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  Class 2 Device Recall iTotal Cruciate Retaining (CR) Knee Replacement System see related information
Date Initiated by Firm October 18, 2016
Create Date November 25, 2016
Recall Status1 Terminated 3 on December 07, 2016
Recall Number Z-0658-2017
Recall Event ID 75553
510(K)Number K160025  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile
Catalog Number: TCR-111-1111.

Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use
of a prosthetic device.
Code Information Serial Numbers: 0381024; 0381042 Exp Date: 2017-02-28
Recalling Firm/
Manufacturer		 ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact SAME
781-345-9001
Manufacturer Reason
for Recall		 Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
FDA Determined
Cause 2		 Labeling Change Control
Action ConforMIS notified the sales representative on 10/18/16 after it became aware of the device mix-up. The sales representative was requested to return any remaining components from iTotal CR kit S/N: 0381042.
Quantity in Commerce 2 units
Distribution Distributed to the states of CO and NV.
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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