Maxima 1127260Recalls & reported problems
Henry Schein, Inc. · Maxima Suture PTFE · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040001254), received between Mar 24, 2021 and Mar 24, 2021 — classified as 1 malfunction.
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 24, 2021Break; Break
ACCORDING TO THE REPORTER, "THERE WAS NO HARM OR INJURY TO PATIENT. I DO NOT HAVE ANY MORE SPECIFICS TO THE COMPLAINT OTHER THAN THEY USED 4 PACKS AND THEY KEPT BREAKING."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11565901 ↗
Other SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE devices
- CYTOSURG T8665CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene3 reports
- Cytoplast™ PTFE Suture CS0618PREMOsteogenics Biomedical Inc · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- MONOTEX T8695CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene2 reports
- Maxima 1127253Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- CYTOSURG T8682CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
- Maxima 1127256Henry Schein, Inc. · SUTURE, SURGICAL, NONABSORBABLE, EXPANDED, POLYTETRAFLOUROETHYLENE1 report
- MONOTEX T8001CRiverpoint Medical, LLC · Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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