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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 Medtronicsee related information
Date Initiated by FirmJune 29, 2016
Create DateAugust 15, 2016
Recall Status1 Terminated 3 on December 12, 2017
Recall NumberZ-2541-2016
Recall Event ID 74672
510(K)NumberK063091 
Product Classification Mesh, surgical, polymeric - Product Code FTL
ProductTRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Code Information model number  NMRM6122   lot number  16E03727 16E05728  model number  NMRM6133  lot number  16E02726 16E09730 
Recalling Firm/
Manufacturer		 TYRX Inc.
1 Deerpark Dr Ste G
Monmouth Junction NJ 08852-1920
For Additional Information ContactMr. 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
ActionMedtronic 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 Commerce194 units
DistributionUS Nationwide Distribution
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = FTL
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