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U.S. Department of Health and Human Services

Class 2 Device Recall ConforMIS

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  Class 2 Device Recall ConforMIS see related information
Date Initiated by Firm August 31, 2015
Date Posted October 21, 2015
Recall Status1 Terminated 3 on March 02, 2016
Recall Number Z-0140-2016
Recall Event ID 72108
510(K)Number K133256  K132640  
Product Classification Knee arthroplasty implantation system - Product Code OOG
Product ConForMIS iUNI Unicondylar Knee Replacement System
iUNI G2, Right Lateral
Catalog Number: M57220600240 (US)
M5722INT0600240 (OUS)
Code Information Serial Numbers (US):  0353697 0354749 0349417 0354328 Serial Number (OUS): 0352836 0355233 
Recalling Firm/
ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact
Manufacturer Reason
for Recall
May contain small amounts of ethylene glycol residue
FDA Determined
Cause 2
Process design
Action ConForMIS issued a Press on August 31, 2015 to the general public The sales force was notified through email. The sales personnel for affected accounts that had upcoming surgeries scheduled were asked to confirm that the affected surgeries were cancelled and that the devices were not used in surgery (Formal notification letters will be distributed to the affected accounts by Tuesday, September 8, 2015. The user required to confirm their understanding of the recall and to return any unused product to ConforMIS. Distribution of the letters conducted in two phases as described below: Phase 1-Surgeons with product for which the surgery has not yet been completed Phase 2-Surgeons for whom product was confirmed to have been consumed/implanted. An updated Surgeon letter dated September 8, 2015 issued includes additional information for devices that have been used in surgery. Contact your local ConforMIS representative or Amita Shah, at 17813459164.
Quantity in Commerce 6 units
Distribution Distributed Nationwide and in Germany, Switzerland, and UK.
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 = OOG and Original Applicant = CONFORMIS, INC.