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U.S. Department of Health and Human Services

Class 2 Device Recall TruMatch CMF Titanium 3D Printed Implant System

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  Class 2 Device Recall TruMatch CMF Titanium 3D Printed Implant System see related information
Date Initiated by Firm February 03, 2020
Create Date April 06, 2020
Recall Status1 Terminated 3 on March 20, 2020
Recall Number Z-1485-2020
Recall Event ID 85080
510(K)Number K170272  
Product Classification Plate, bone - Product Code JEY
Product TRUMATCH Orthognathics - Genioplasty Surgical Kit, Add-on, Catalog Number: SD980.013
Code Information Lot Number: ME19-ZIK-VIK, UDI: (01)05420060380136(10)ME19ZIKVIK
Recalling Firm/
Manufacturer		 Materialise N.V.
Technologielaan 15
Heverlee Belgium
Manufacturer Reason
for Recall		 Custom surgical kits contain a plate different than indicated by the package labeling.
FDA Determined
Cause 2		 Employee error
Quantity in Commerce 1
Distribution US: NY. OUS: Italy
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 = JEY and Original Applicant = Materialise NV
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