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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal CR Total Knee Replacement System

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  Class 2 Device Recall iTotal CR Total Knee Replacement System see related information
Date Initiated by Firm December 03, 2018
Create Date April 08, 2019
Recall Status1 Terminated 3 on June 26, 2020
Recall Number Z-1108-2019
Recall Event ID 82100
510(K)Number K180906  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)
M5725INT0600010 (Model No.)

Product Usage:
The iTotal CR Knee Replacement System is 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 that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral, or bicompartmental prosthesis.
Code Information Serial Numbers 0432428 and 0432212
Recalling Firm/
Manufacturer		 Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
For Additional Information Contact Tom Haueter
781-345-9161
Manufacturer Reason
for Recall		 The kits were prepared with incorrect patient ID labels and may contain incorrect components.
FDA Determined
Cause 2		 Labeling mix-ups
Action Customers were contacted via email on 12/3/18. Customers were contacted via email on 12/3/18. The customer was instructed to return the product.
Quantity in Commerce 2
Distribution Worldwide Distribution - US Nationwide in the state: NC and the country of: Hungary.
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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