TYRX Neuro Absorbable Antibacterial Envelope Recalled for Manufacturing Validation Issues
TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope because manufacturing processes were not adequately validated.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk medical device (implanted pacemaker/ICD) where the risk of harm is theoretical due to unvalidated manufacturing processes, but no injuries or illnesses have been reported.
Plain-English summary
TYRX Inc. is recalling 194 units of the TRYX Neuro Absorbable Antibacterial Envelope. This medical device is indicated for the stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD). The recall was initiated because the processes of spaying, welding, drying oven, and polymer were not adequately validated.
The affected products are distributed nationwide in the United States. The recall involves specific model numbers NMRM6122 and NMRM6133, with lot numbers 16E03727, 16E05728, 16E02726, and 16E09730. The FDA has classified this recall as Class II.
Healthcare providers and patients should contact TYRX Inc. for further instructions regarding the return or replacement of these devices. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Manufacturer
- TYRX Inc.
- Affected units
- 194
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by TYRX Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · TYRX Inc.
See all →- HighTYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
FDA (Devices) · 2016-08-24
- HighTYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
FDA (Devices) · 2016-08-24
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