Date Initiated by Firm | June 29, 2016 |
Create Date | August 15, 2016 |
Recall Status1 |
Terminated 3 on December 12, 2017 |
Recall Number | Z-2539-2016 |
Recall Event ID |
74672 |
510(K)Number | K063091 |
Product Classification |
Mesh, surgical, polymeric - Product Code FTL
|
Product | TRYX Antibacterial Envelope Rx Only
Product Usage:
Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD) |
Code Information |
model number CMRM3122 lot number 15F30614 15F30614-A 15H10630 15K29659 16B05695 model number CMRM3133 lot number 15F18607 15G14620 15J29647 16C03706 |
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 | 3460 units |
Distribution | US Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FTL
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