Device product
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Z-2540-2016
Product summary
- Firm
- TYRX Inc.
- Event
- Event 74672
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2993 units
- Official record key
device-enforcement:Z-2540-2016
Official wording
Reason: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Code information: model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.