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U.S. Department of Health and Human Services

Class 2 Device Recall Signature Personalized Patient Care System

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  Class 2 Device Recall Signature Personalized Patient Care System see related information
Date Initiated by Firm May 03, 2016
Create Date June 09, 2016
Recall Status1 Terminated 3 on June 28, 2016
Recall Number Z-1941-2016
Recall Event ID 74213
510(K)Number K102795  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Signature TKA GDE/MDL Set 04-05

Patient-specific surgical guide and instrument set.
Code Information Lot #154970
Recalling Firm/
Manufacturer		 Materialise USA LLC
44650 Helm Ct
Plymouth MI 48170-6061
For Additional Information Contact Customer Service
734-259-7016
Manufacturer Reason
for Recall		 A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
FDA Determined
Cause 2		 Process control
Action Materialise sent an URGENT: Signature Personalized Patient Care System Knee Guides Notification dated May 3, 2016. It was sent to the affected customer via email with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Contact Materialise customer service for additional information or to find a status of the second patient specific surgical guide Monday through Friday, 8:00AM to 4:30 PM, Eastern Time.734-259-7016
Quantity in Commerce 1
Distribution One consignee, Indiana.
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 = MATERIALISE N.V.
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