CLASS II Device recall · Reported 24 Aug 2016 · FDA Enforcement Report
TRYX Neuro Absorbable Antibacterial Envelope recalled by TYRX
TYRX is recalling TRYX Neuro Absorbable Antibacterial Envelope, distributed nationwide in the US. The recall was initiated on 29 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2541-2016
- FDA event ID
- 74672
- Recalling firm
- TYRX, Monmouth Junction, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2016
- FDA classified
- 15 Aug 2016
- Reported
- 24 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Pacemakers & Defibrillators
Timeline
| 29 Jun 2016 | Recall initiated by company | |
| 15 Aug 2016 | Classified by FDA | +47 days |
| 24 Aug 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Product as listed by the FDA
TRYX Neuro Absorbable Antibacterial Envelope Product Usage: Indicated for stabilization of implanted pacemakers (IPG) and/or implantable cardioverter defibrillators (ICD)
Where it was distributed
US Nationwide Distribution
Stores named: Walmart
Questions about this recall
Is TRYX Neuro Absorbable Antibacterial Envelope recalled?
Yes. TYRX recalled TRYX Neuro Absorbable Antibacterial Envelope on 29 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2541-2016.
Why was it recalled?
TRYX products are being recalled since the processes of spaying, welding, drying oven and polymer were not adequately validated.
Which lots are affected?
model number NMRM6122 lot number 16E03727 16E05728 model number NMRM6133 lot number 16E02726 16E09730
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from TYRX
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TRYX Absorbable Antibacterial Envelope recalled by TYRX | TYRX | Other | Nationwide |
| Device | CLASS II | TRYX Antibacterial Envelope recalled by TYRX | TYRX | Other | Nationwide |
Other Pacemakers & Defibrillators recalls
All 494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DermaV Laser System recalled by Lutronic | Lutronic | Other | Nationwide |
| Device | CLASS II | Convenience kits containing select SKUs of Polycarbonate recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits: Loop Pack DYNJ61460C Open Heart recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS II | Medline convenience kits: Acl Pack DYNJ64161C Arthroscopy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Medline convenience kits: Bib AV Fistula Pack DYNJ58304B recalled | Medline Industries | Device Malfunction | Nationwide |