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U.S. Department of Health and Human Services

Class 2 Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System

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  Class 2 Device Recall iTotal Posterior Stabilized (PS) Knee Replacement System see related information
Date Initiated by Firm July 24, 2017
Create Date February 13, 2018
Recall Status1 Terminated 3 on February 01, 2019
Recall Number Z-0600-2018
Recall Event ID 78902
510(K)Number K161668  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/

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: 0398482 & 0399917 Expiration Date: 12/31/2017
Recalling Firm/
ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact
Manufacturer Reason
for Recall
Implant kit mislabeled
FDA Determined
Cause 2
Employee error
Action On July 10, 2017, ConforMIS notified their Sales Representatives about a possible product mislabeling. On July 11, 2017, ConforMIS secured impacted product. On July 21, 2017, ConforMIS issued a Memorandum to their Sales Representatives. ConforMIS requested that the kits be returned to ConforMIS for investigation and disposition. For further questions, please call (781) 345-9001.
Quantity in Commerce 2 units
Distribution US Distribution to the states of :CA and TX.
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.