TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Recall
- Recall Number
- Z-2541-2016
- Event Number
- 74672
- Firm
- TYRX Inc.
- FEI Number
- 3005619263
- Product Code
- FTL
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 29, 2016
- Terminated
- December 12, 2017
- Address
- 1 Deerpark Dr, Ste G, Monmouth Junction, NJ, 08852-1920
Description
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
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 [email protected] or fax to Medtronic at 651-367-0612 Attention Customer Focused Quality.
US Nationwide Distribution
194 units