Recall Z-2540-2016 ยท FTL Mesh, Surgical, Polymeric
TYRX Inc.
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
| Date | Jun 29, 2016 |
| Status | Terminated |
| Reason | TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. |
| Root cause | 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 e |
| Quantity | 2993 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063091 | PIVIT CRM (TYRX ANTIMICROBIAL PACEMAKER POUCH), MODEL CMRM-0601 Tyrx Pharma, Inc., Jan 16, 2008 |