Z-2540-2016 Class II Terminated
FDA device recall Z-2540-2016 was initiated by TYRX Inc. on June 29, 2016 and is designated Class II. Reason for recall: TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. The recall status is terminated (terminated December 12, 2017). Affected quantity: 2993 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 24, 2016
- Initiation Date
- June 29, 2016
- Termination Date
- December 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2993 units
Product Description
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Reason for Recall
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Distribution Pattern
US Nationwide Distribution
Code Information
model number CMRM6122 lot number 16E03727 16E05728 model number CMRM6133 lot number 16E02726 16E06729