TYRX Absorbable Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope because key 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. Per the rubric, a Class II recall without explicit reports of hospitalization or significant injury falls under the 'High' category, representing a risk-of-harm product where injury has not yet been reported.
Plain-English summary
TYRX Inc. is recalling 2,993 units of the TRYX Absorbable Antibacterial Envelope. This medical device is indicated for the stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD). The affected units were distributed nationwide in the United States.
The recall was initiated because the processes of spaying, welding, drying oven, and polymer were not adequately validated. The specific model numbers and lot numbers affected are CMRM6122 (lots 16E03727, 16E05728) and CMRM6133 (lots 16E02726, 16E06729).
The source text does not specify reported illnesses or injuries. Consumers and healthcare providers should contact TYRX Inc. or their medical device supplier for instructions on how to proceed with the affected units.
The recalled product
- Product
- TRYX Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
- Manufacturer
- TYRX Inc.
- Affected units
- 2,993
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
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See all →- HighTYRX Antibacterial Envelope Recalled for Unvalidated Manufacturing Processes
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