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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic

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  Class 2 Device Recall Medtronic see related information
Date Initiated by Firm June 29, 2016
Create Date August 15, 2016
Recall Status1 Terminated 3 on December 12, 2017
Recall Number Z-2540-2016
Recall Event ID 74672
510(K)Number K063091  
Product Classification Mesh, surgical, polymeric - Product Code FTL
Product TRYX Absorbable Antibacterial Envelope

Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Code Information model number  CMRM6122   lot number 16E03727 16E05728  model number  CMRM6133  lot number  16E02726 16E06729 
Recalling Firm/
Manufacturer		 TYRX Inc.
1 Deerpark Dr Ste G
Monmouth Junction NJ 08852-1920
For Additional Information Contact Mr. Carlos Alfonzo
732-246-8676
Manufacturer Reason
for Recall		 TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
FDA Determined
Cause 2		 Process control
Action Medtronic sent an Urgent Medical Device Recall letter dated June 2016 to affected customers. The letter identified the affected product problem and actions to be taken. Customers are asked to immediately remove and quarantine all unused product that remains in inventory, return unused product to Medtronic and contacted the local Medtronic representative or Customer Service at 800-848-9300 to assist with the return and credit of unused product. Medtronic will provide credit for all non-expired, unused product. The customer should complete the attached Customer Confirmation Certificate and email to RS.CFQFCA@Medtronic.com or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.
Quantity in Commerce 2993 units
Distribution US Nationwide Distribution
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 = FTL and Original Applicant = TYRX PHARMA, INC.
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