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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-0145-2016
Recall Event ID 72108
510(K)Number K142161  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Catalog Number: M57250600010 (US)
M5725INT0600010 (OUS)
Code Information Serial Numbers (US):  0348488 0355066 0355392 0355317 0353561 0354483 0354945 0355261 0355989 0347842 0355561 0351297 0354882 0354343 0354746 0356253 0355288 0351033 0354279 0354994 0352643 0353878 0354579 0353642 0353612 0353882 0352852 0354051 0355244 0354198 0353638 0355030 0354485 0352979 0355292 0354752 0354992 0354915 0355643 0355534 0354406 0354834 0355706 0353989 0355877 0355175 0352628 0354616 0354740 0353368 0352993 0354481 0354768 0355262 0355375 0353458 0355484 0355865 0336962 0355154 0353183 0353452 0352902 0353126 0353139 0353927 0354087 0353911 0355624 0355128 0354275 0354378 0352822 0353001 0353300 0353327 0352113 0354712 0354918 0354813 0353104 0353705 0352746 0353487 0354216 0353915 0354542 0354690 0354875 0354151 0354522 0355219 0355499 0351896 0351998 0354374 0354730 0354923 0354800 0353898 0354486 0354056 0354952 0354213 0354342 0353964 0353717 0354837 0353406 0355368 0354941 0347736 0353823 0353827 0353465 0353595 0354174 0354492 0355152 0352954 0353203 0354649 0354365 0355158 0355492 0353546 0351478 0352263 0352265 0353735 0353747 0352455 0353472 0353990 0352910 0354442 0355491 0354477 0353848 0350752 0349020 0354936 0353182 0353910 0355258 0352741 0354222 0354224 0354314 0355354 0355457 0353524 0354129 0354537 0353495 0354822 0351981 0353313 0354333 0354928 0354897 0353656 0354006 0354090 0355187 0354122 0353983 0354546 0354934 0354002 0353397 0355160 0354304 0354581 0352577 0353030 0354254 0353046 0352985 0354874 0355129 0354026 0355346 0355431 0355570 0355220 0353002 0351811 0352037 0352376 0354614 0351800 0354185 0354248 0355733 0354270 0354105 0352799 0355126 0352886 0354038 0355498 0353395 0352788 0354249 0354080 0354152 0354751 0353317 0353468 0353654 0353473 0354188 0353326 0354473 0352906 0349619 0352571 0353360 0353426 0354015 0354307 0354101 0353652 0353869 0355010 0355698 0352948 0353559 0352380 0354650 0352891 0348392 0350639 0353181 Serial Numbers: OUS 0350255 0354385 0353821 0354323 0351187 0354283 0353298 0353715 0348897 0354012 0355089 0354076 0354634 0354504 0348956 0354636 0353926 0355203 0355232 0349138 0352586 0352734 0354977 0354645 0355355 0355208 0355034 0355503 0352434 0355665 0354811 0354861 0354316 0353620 0355251 0351845 0352009 0353775 0355608 0355195 0354282 0352607 0349828 0351048 0352403 0353033 0350960 0352275 0352587 0354409 0354287 0354383 0353804 0351991 0351546 0354071 0354550 0353299 0354397 0351118 0353842 0351132 0354066 0354984 0355338 0354322 0353922 0354239 0354120 0353713 0354682 0354536 0354258 0354398 0354728 0353639 0354182 0354402 
Recalling Firm/
Manufacturer
ConforMIS, Inc.
28 Crosby Dr
Bedford MA 01730-1402
For Additional Information Contact
781-345-9001
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 313 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 = JWH and Original Applicant = CONFORMIS, INC.
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