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TYRX Inc. recalls TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/
Recalled August 24, 2016 · FDA recall Z-2540-2016 · TYRX
Hazard
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated. · FDA Class II
Units
2993 units
Sold at
US Nationwide Distribution
Description
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Product
TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Manufacturer(s)
TYRX Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →