MONOTEX T8695CRecalls & reported problems
Riverpoint Medical, LLC · SUTURE · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812444020649), received between Mar 17, 2021 and May 28, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Material Integrity Problem
ACCORDING TO THE REPORTER, "CUSTOMER STATED THAT SOON AS THEY PULL THE SUTURE OUT OF THE SEALED PACKAGE THE NEEDLE DETACHES FROM THE THREAD."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25316910 ↗MalfunctionMar 17, 2021Break; Break
ACCORDING TO THE REPORTER, "THE NEEDLES WERE NOT ATTACHED TO THE SUTURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11504797 ↗
Other Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene devices
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- Cytoplast™ PTFE Suture CS0618PREMOsteogenics Biomedical Inc · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- MONOTEX T8001CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
- CYTOSURG T8682CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
- Maxima 1127253Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127260Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- Maxima 1127256Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.